FDA 510(k) Applications for Medical Device:
Intervertebral Fusion Device With Bone Graft, Cervical
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K121741 | 4-WEB, INC. |
13540 GUILD AVE. | APPLE VALLEY | MN | 55124 |
| K221266 | 4WEB Medical, Inc. |
2801 Network Blvd., Suite 620 | Frisco | TX | 75034 |
| K173159 | 4Web, Inc. |
2801 Network Blvd.,Suite 620 | Frisco | TX | 75034 |
| K181471 | Absolute Advantage Medical, LLC |
2731 Millbrook Road | Fayetteville | NC | 78681 |
| K121569 | ACCEL SPINE |
14850 Quorum Dr Ste 220 | Dallas | TX | 75254 |
| K143450 | ACKERMANN INSTRUMENTE GMBH |
EISENBAHNSTR. 65-67 | RIETHEIM, WEILHEIM | D-78604 | |
| K083425 | ADAPTIVE SPECIALTY, LLC |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K191812 | Additive Device, Inc. (ADI) d/b/a restor3d |
311 W Corporation St | Durham | NC | 27701 |
| K193359 | Additive Implants, Inc |
3101 E. Shea Blvd, Suite 122 | Phoenix | AZ | 85028 |
| K182477 | Additive Implants, LLC |
3101 E. Shea Blvd, Suite 114 | Pheonix | AZ | 85028 |
| K190291 | Addivation Medical, LLC |
44 Riverdale Avenue | Monmouth Beach | NJ | 07750 |
| K123909 | AESCULAP IMPLANT SYSTEM, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K083311 | AESCULAP IMPLANT SYSTEMS, INC. |
3773 CORPORATE PWKY. | CENTER VALLEY | PA | 18034 |
| K112361 | ALLIANCE PARTNERS, LLC |
33490 PIN OAK PARKWAY | AVON LAKE | OH | 44012 |
| K133321 | ALLIANCE PARTNERS, LLC |
33490 PIN OAK PARKWAY | AVON LAKE | OH | 44012 |
| K173128 | Alliance Partners, LLC |
14206 Northbrook Dr. | San Antonio | TX | 78232 |
| K222973 | Alphatec Spine Inc. |
1950 Camino Vida Roble | Carlsbad | CA | 92008 |
| K181435 | Alphatec Spine, Inc. |
5818 El Camino Real | Carlsbad | CA | 92008 |
| K081730 | ALPHATEC SPINE, INC. |
2051 PALOMAR AIRPORT ROAD | CARLSBAD | CA | 92011 |
| K172253 | Altus Partners, LLC |
1340 Enterprise Drive | West Chester | PA | 19380 |
| K142264 | Amedica Corp. |
1885 West 2100 South | Salt Lake City | UT | 84119 |
| K173453 | Amedica Corp. |
1885 W 2100 S | Salt Lake City | UT | 84119 |
| K120143 | APOLLO SPINE |
128 Blye HIll Landing | Newbury | NH | 03255 |
| K173324 | Astura Medical |
3186 Lionshead Ave, Suite 100 | Carlsbad | CA | 92010 |
| K160154 | Astura Medical |
5670 El Camino Real, Suite B | Carlsbad | CA | 92008 |
| K081880 | ATLAS SPINE INC. |
1555 JUPITER PARK DR., STE. 4 | JUPITER | FL | 33458 |
| K180675 | Atlas Spine, Inc. |
1555 Jupiter Park Drive, Suite 1 | Jupiter | FL | 33458 |
| K202302 | Atlas Spine, Inc. |
1555 Jupiter Park Drive, Suite 1 | Jupiter | FL | 33458 |
| K210521 | Aurora Spine, Inc. |
1930 Palomar Point Way, Suite 103 | Carlsbad | CA | 92008 |
| K181140 | Axis Orthopaedics |
34355 Poppy Wood St. | Soldotna | AK | 99669 |
| K191537 | Back 2 Basics Direct, LLC |
6701 Rockside Road, Suite 200 | Independence | OH | 44131 |
| K200458 | BeSpoke Technologies |
118 S. Cherry St, Suite E | Winston-Salemn | NC | 27101 |
| K132483 | BK MEDITECH CO., LTD. |
PO BOX 560 | STILLWATER | MN | 55082 |
| K203520 | Blustone Synergy, LLC |
5520 Ventana Ct | Pueblo | CO | 81005 |
| K122518 | BM KOREA CO., LTD. |
951 STARBUCK ST. UNIT J | FULLERTON | CA | 92833 |
| K111820 | BM KOREA CO., LTD. |
951 STARBUCK ST. UNIT J | FULLERTON | CA | 92833 |
| K102449 | BRIGHT SPINE, INC |
799 N.E. 71ST STREET | BOCA RATON | FL | 33487 |
| K133529 | CAMBER SPINE |
90 S. NEWTOWN STREET RD. | NEWTOWN SQUARE | PA | 19073 |
| K170550 | Camber Spine Technologies |
418 E. Lancaster Avenue | Wayne | PA | 19087 |
| K172446 | Camber Spine Technologies |
418 E. Lancaster Avenue | Wayne | PA | 19087 |
| K142586 | CAPTIVA SPINE |
967 ALTERNATE A1A #1 | JUPITER | FL | 33477 |
| K110585 | CAPTIVA SPINE, INC |
2361 NW 105TH LANE | SUNRISE | FL | 33322 |
| K181229 | Captiva Spine, Inc. |
967 N. Alternate A1A, Ste. 1 | Jupiter | FL | 33477 |
| K222874 | CarboFix Orthpedics Ltd. |
11 Ha'Hoshlim Street | Herzeliya | 4672411 | |
| K100698 | CARDINAL SPINE, LLC |
11234 EL CAMINO REAL, | SAN DIEGO | CA | 9213 |
| K091531 | CHOICE SPINE, LLP |
306 ERIN DRIVE | KNOXVILLE | TN | 37919 |
| K191621 | ChoiceSpine, LLC |
400 Erin Drive | Knoxville | TN | 37919 |
| K201643 | ChoiceSpine, LLC |
400 Erin Drive | Knoxville | TN | 37919 |
| K183397 | ChoiceSpine, LP |
400 Erin Drive | Knoxville | TN | 37922 |
| K130853 | CLARIANCE |
1835 MARKET STREET | PHILADELPHIA | PA | 19103 |
| K173148 | coLigne, AG |
Utoquai 43 | Zurich | CH 8008 | |
| K150847 | CORELINK LLC |
7606 FORSYTH BLVD | CLAYTON | MO | 63105 |
| K230329 | Corelink, LLC |
2072 Fenton Logistics Blvd. | St. Louis | MO | 63026 |
| K162496 | CoreLink, LLC |
7911 Forsyth Blvd, Suite # 200 | St. Louis | MO | 63105 |
| K162682 | CTL Medical Corporation |
4550 Excel Parkway, Suite 300 | Addison | TX | 75001 |
| K172212 | CTL Medical Corporation |
4550 Excel Parkway, Suite 300 | Addison | TX | 75001 |
| K172788 | CTL Medical Corporation |
4550 Excel Parkway, Suite 300 | Addison | TX | 75001 |
| K220513 | CTL Medical Corporation |
4550 Excel Parkway | Addison | TX | 75001 |
| K213030 | Curiteva, Inc. |
25127 Will McComb Drive | Tanner | AL | 35671 |
| K181261 | Curiteva, LLC |
25127 Will McComb Drive | Tanner | AL | 35671 |
| K092904 | CUSTOM SPINE, INC. |
1140 PARSIPPANY BLVD. | PARSIPPANY | NJ | 07054 |
| K180674 | Cutting Edge Spine, LLC |
101 Waxhaw Professional Park, Suite A | Waxhaw | NC | 28173 |
| K151496 | Degen Medical |
1321-C North Cashua Drive | Florence | SC | 29501 |
| K222276 | DePuy Spine |
325 Paramount Dr. | Raynham | MA | 02767 |
| K162220 | DIO MEDICAL CO., LTD |
101-105 MEGACENTER, SK TECHNOPARK, | SAGIMAKGOL-RO JUNGWON-GU SEONGNAM-SI | 124 | |
| K122872 | DIO MEDICAL CO., LTD. |
325 N. PUENTE ST | BREA | CA | 92821 |
| K122444 | EISERTECH, LLC |
1133 COLUMBIA STREET | SAN DIEGO | CA | 92101 |
| K110915 | EISERTECH, LLC |
2555 FRONT STREET | SAN DIEGO | CA | 92103 |
| K212701 | Eminent Spine |
2004 Ventura Drive, Suite #100 | Plano | TX | 75093 |
| K160324 | EVOLUTION SPINE, LLC |
4225 OFFICE PARKWAY | DALLAS | TX | 75204 |
| K150130 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K141129 | EXACTECH, INC. |
4628 NORTHPARK DRIVE | COLORADO SPRINGS | CO | 80918 |
| K103655 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K223231 | FloSpine |
3651 FAU Blvd., Suite 400 | Boca Raton | FL | 33431 |
| K210890 | G Surgical LLC |
9433 Bee Cave Road Building 3, Suite 101-A | Austin | TX | 78733 |
| K142456 | G SURGICAL, LLC |
5757 Central Ave, Suite G | Boulder | CO | 80301 |
| K213980 | GBS Commonwealth Co., Ltd. |
C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro | Geumcheon-gu | 08507 | |
| K213755 | GBS Commonwealth Co., Ltd. |
C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro | Geumcheon-gu | 08507 | |
| K230708 | GBS Commonwealth Co., Ltd. |
C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro | Geumcheon-gu | 08507 | |
| K202872 | GBS Commonwealth Co., Ltd. |
C-309, Woolim Lion's Valley, 168, Gasan Digital 1-ro | Geumcheon-gu | 08507 | |
| K150812 | Genesys Spine |
1250 Capital of Texas Highway Building Three Suite 600 | Austin | TX | 78746 |
| K130317 | GENESYS SPINE |
1250 CAPITAL OF TEXAS HWY SO. | AUSTIN | TX | 78746 |
| K142218 | GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K173115 | Globus Medical Inc. |
2560 General Armistead Ave. | Audubon | PA | 19403 |
| K191243 | Globus Medical Inc. |
2560 General Armistead Ave. | Audubon | PA | 19403 |
| K222270 | Globus Medical Inc. |
2560 General Armistead Ave. | Audubon | PA | 19403 |
| K173722 | Globus Medical Inc. |
2560 General Armistead Ave. | Audubon | PA | 19403 |
| K180909 | Globus Medical Inc. |
2560 General Armistead Avenue | Audubon | PA | 19403 |
| K072991 | GLOBUS MEDICAL, INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K153517 | GS Medical Co., Ltd. |
90, Osongsaengmyeong 4-ro | Osong-eup, Cheongwon-gun | 363-951 | |
| K200592 | GS Medical Co., Ltd. |
90, Osongsaengmyeong 4-ro | Osong-eup, Cheongwon-gun | 363-951 | |
| K222004 | HAPPE Spine |
220 Lyon Street, NW, Suite 500 | Grand Rapids | MI | 49503 |
| K180364 | HD LifeSciences LLC |
38 Montvale Ave Ste 380 | Stoneham | MA | 02180 |
| K222988 | HT Medical d.b.a. Xenix Medical |
111 W. Jefferson Street, Suite 100 | Orlando | FL | 32081 |
| K170318 | HT Medical, LLC |
6316 E. 102nd Street | Tulsa | OK | 74137 |
| K192897 | icotec ag |
Industriestrasse 12 | 9450 Altstaetten(SG) | ||
| K172480 | icotec ag |
Industriestrasse 12 | 9450 Altstaetten | ||
| K230026 | Implanet, S.A. |
Technopole Bordeaux Montesquieu, Allee Francois Magendie | Martillac | 33650 | |
| K132991 | INNOVASIS, INC. |
614 EAST 3900 SOUTH | SALT LAKE CITY | UT | 84107 |
| K181115 | Innovasis, Inc. |
614 East 3900 South | Salt Lake City | UT | 84107 |
| K220875 | Innovasis, Inc. |
614 E 3900 S | Salt Lake City | UT | 84107 |
| K223510 | Innovasis, Inc. |
614 E 3900 South | Salt Lake City | UT | 84107 |
| K132718 | INTEGRITY SPINE |
14001 HUNTERS PASS | AUSTIN | TX | 78734 |
| K223043 | Integrity Spine |
414 W Sunset Rd 205 | San Antonio | TX | 78209 |
| K081614 | INTERBODY INNOVATIONS, LLP |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681 |
| K111484 | INTUITIVE SPINE, LLC |
33490 PIN OAK PARKWAY | AVON LAKE | OH | 44012 |
| K212266 | Jeil Medical Corporation |
702, 703, 704, 705, 706, 804, 805, 807, 812, 815-ho, | Seoul | 08378 | |
| K201793 | JMT Co., Ltd |
70-39, Gwonyul-ro 1203 beon-gile, Baekseok-eup | Yangju-si | 11517 | |
| K212038 | K&J Consulting Corporation |
2260 Glenview dr | Lansdale | PA | 19446 |
| K160125 | K2M |
751 Miller Drive SE | Leesburg | VA | 20175 |
| K101302 | K2M, INC. |
751 MILLER DR.,SE | LEESBURG | VA | 20175 |
| K103169 | K2M, INC. |
751 MILLER DR.,SE | LEESBURG | VA | 20175 |
| K123388 | K7 LLC |
PO BOX 566 | CHESTERLAND | OH | 44026-2141 |
| K213115 | Kahtnu Surgical, Inc |
170 E. Corral Ave. Suite 1 | Soldotna | AK | 99669 |
| K133815 | KALITEC DIRECT, LLC |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K180401 | Kalitec Direct, LLC |
618 E. South Street | Orlando | FL | 32801 |
| K212450 | Keos |
1824 Colonial Village Lane | Lancaster | PA | 17601 |
| K120840 | L&K BIOMED CO., LTD |
#1104, ACE HIGH-END TOWER 3 | GEUMCHEON-GU, SEOUL | 153-803 | |
| K143360 | L&K BIOMED Co., Ltd |
#201, 202 16-25, Dongbaekjungang-ro 16 beon-gil | Giheung-gu, Yongin-si | 446-916 | |
| K151677 | L&K BIOMED Co.,Ltd. |
#201, 202 16-25, Dongbaekjungang-ro 16 beon-gil | Giheung-gu,Yongin-si | 446-916 | |
| K103660 | LANX, INC. |
390 INTERLOCKEN CRESCENT | BROOMFIELD | CO | 80021 |
| K091088 | LDR SPINE USA |
4030 WEST BRAKER LANE | AUSTIN | TX | 78759 |
| K113559 | LDR SPINE USA INC. |
13785 RESEARCH BOULEVARD | AUSTIN | TX | 78750 |
| K192208 | Legend Spine Technologies |
1803 Apple Tree Lane | Bethlehem | PA | 18015 |
| K093093 | LIFE SPINE |
2401 W. HASSELL RD. | HOFFMAN ESTATES | IL | 60169 |
| K161127 | LIFE SPINE INC. |
13951 S. Quality Drive | Huntley | IL | 60142 |
| K111835 | LIFE SPINE, INC |
2401 W. HASSELL RD SUITE 1535 | HOFFMAN ESTATES | IL | 60169 |
| K211501 | lntelivation, LLC |
70 Gruber Lane | Saint Simons Island | GA | 31522 |
| K200549 | Lucero Medical, LLC |
6815 West Streetsboro | Richfield | OH | 44286 |
| K123206 | MAXIM SURGICAL |
1565 NORTH CENTRAL EXPRESSWAY | RICHARDSON | TX | 75080 |
| K112862 | MEDACTA INTERNATIONAL |
4725 Calle Quetzal, Unit B | Camarillo | CA | 93012 |
| K142744 | Medacta International |
Strada Regina | Castel San Pietro | ch 6874 | |
| K172587 | Medacta International SA |
Strada Regina | Castel San Pietro | CH-6874 | |
| K100484 | MEDICREA |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K122850 | MEDITECH ADVISORS, LLC |
200 NOMER AVENUE | ASHLAND | MA | 01721 |
| K150788 | MEDITECH SPINE, LLC |
1447 PEACHTREE ST NE SUITE 440 | ATLANTA | GA | 30309 |
| K142345 | MEDITECH SPINE, LLC |
1447 PEACHTREE ST NE SUITE 44 | ATLANTA | GA | 30309 |
| K201506 | Meditech Spine, LLC |
1447 Peachtree St NE Suite 440 | Atlanta | GA | 30309 |
| K120517 | MEDOS INTERNATIONAL SARL |
325 PARAMOUNT DR | RAYNHAM | MA | 02767 |
| K112444 | MEDTRONIC SOFAMOR DANCK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K153373 | Medtronic Sofamor Danek |
1800 Pyramid Place | Memphis | TN | 38132 |
| K100214 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K111264 | MEDTRONIC SOFAMOR DANEK USA |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K142450 | MEDTRONIC SOFAMOR DANEK USA, INC |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K153438 | MEDTRONIC SOFAMOR DANEK USA, INC |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K130177 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K133653 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K100967 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K132584 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K160528 | MEDTRONIC SOFAMOR DANEK, USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K212792 | Medynus Inc. |
18 Technology Dr. Ste 109 | Irvine | CA | 92618 |
| K121320 | MEDYSSEY CO., LTD. |
8001 N. LINCOLN AVE | SKOKIE | IL | 60077 |
| K132732 | MEDYSSEY USA, INC. |
1550 E. HIGGINS ROAD, STE 123 | ELK GROVE VILLAGE | IL | 60007 |
| K161649 | Met 1 Technologies, LLC |
154 N. Festival Dr., Ste. F | El Paso | TX | 79912 |
| K222806 | Met One Technologies, LLC |
513 W. San Antonio Ave, Suite C | El Paso | TX | 79901 |
| K200685 | MiRus, LLC |
1755 West Oak Parkway, Suite 100 | Marietta | GA | 30062 |
| K190618 | MiRus, LLC |
2150 Newmarket Parkway | Marietta | GA | 30067 |
| K101363 | MUSCULOSKELETAL CLINICAL REGULATORY ADVISERS |
1331 H STREET NW, 12TH FLOOR | WASHINGTON | DC | 20005 |
| K230936 | Nanovis LLC |
5865 East State Rd. 14 | Columbia City | IN | 46725 |
| K191822 | Nanovis LLC |
5865 East State Rd. 14 | Columbia City | IN | 46725 |
| K140280 | NANOVIS, LLC |
PO BOX 566 | CHESTERLAND | OH | 44026 |
| K110442 | NANOVIS, LLC |
11234 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
| K201769 | NeuroStructures, Inc. |
199 Technology Drive, Suite 110 | Irvine | CA | 92618 |
| K181590 | NeuroStructures, Inc. |
199 Technology Drive, Suite 110 | Irvine | CA | 92618 |
| K172320 | NeuroStructures, Inc. |
16 Technology Drive | Irvine | CA | 92618 |
| K161608 | NEXT ORTHOSURGICAL |
3270 CORPORATE VIEW | Vista | CA | 92081 |
| K120345 | NEXXT SPINE LLC |
PO BOX 566 | CHESTERLAND | OH | 44026 |
| K171140 | Nexxt Spine LLC |
14425 Bergen Blvd, Suite B | Noblesville | IN | 46060 |
| K200429 | NGMedical GmbH |
Talsperrenblick 5 | Nonnweiler | 66620 | |
| K203444 | NGMedical GmbH |
Talsperrenblick 5 | Nonnweiler | 66620 | |
| K140003 | NUVASIVE, INC. |
7475 LUSK BLVD | SAN DIEGO | CA | 92121 |
| K081611 | NUVASIVE, INC. |
7475 LUSK BLVD | SAN DIEGO | CA | 92121 |
| K223731 | Nuvasive, Inc. |
7475 Lusk Blvd. | San Diego | CA | 92121 |
| K140921 | NUVASIVE, INCORPORATED |
7475 LUSK BOULEVARD | SAN DIEGO | CA | 92121 |
| K142050 | NUVASIVE, INCORPORATED |
7475 LUSK BLVD. | SAN DIEGO | CA | 92121 |
| K150362 | NuVasive, Incorporated |
7475 Lusk Blvd. | San Diego | CA | 92121 |
| K163491 | NuVasive, Incorporated |
7475 Lusk Boulevard | San Diego | CA | 92121 |
| K231735 | NuVasive, Incorporated |
7475 Lusk Boulevard | San Diego | CA | 92121 |
| K162138 | NUVASIVE, INCORPORATED |
7475 LUSK BLVD. | SAN DIEGO | CA | 92121 |
| K172676 | NuVasive, Incorporated |
7475 Lusk Boulevard | San Diego | CA | 92121 |
| K173030 | NuVasive, Incorporated |
7475 Lusk Blvd. | San Diego | CA | 92121 |
| K222015 | Nvision Biomedical Technologies, Inc |
4590 Lockhill Selma | San Antonio | TX | 78249 |
| K190380 | Nvision Biomedical Technologies, Inc. |
4754 Shavano Oak, Suite 101 | San Antonio | TX | 78249 |
| K170074 | Nvision Biomedical Technologies, LLC |
1350 N Loop 1604 E, Suite 103 | San Antonio | TX | 78232 |
| K142328 | NVISION BIOMEDICAL TECHNOLOGIES, LLC |
18618 TUSCANY STONE SUITE 120 | SAN ANTONIO | TN | 78258 |
| K122085 | OMNI SURGICAL, LP DBA SPINE360 |
5000 Plaza on the Lake, Suite 305 | Austin | TX | 78746 |
| K163265 | Orbbo Surgical, LLC |
555 W. 5th Street, 35th Floor | Los Angeles | CA | 90013 |
| K122588 | ORTHO DEVELOPMENT CORP. |
12187 SOUTH BUSINESS PARK DR. | DRAPER | UT | 84020 |
| K121649 | ORTHOFIX |
3451 PLANO PARKWAY | LEWISVILLE | TX | 75056 |
| K101812 | ORTHOFIX INC. |
1720 BRAY CENTRAL DR. | MCKINNEY | TX | 75069 |
| K202949 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K150619 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K211704 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K202666 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K200052 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K203342 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K172437 | Orthofix Inc. |
3451 Plano Parkway | Lewisville | TX | 75056 |
| K142152 | ORTHOFIX, INC. |
3451 PLANO PARKWAY | LEWISVILLE | TX | 75056 |
| K101171 | ORTHOVITA, INC. |
45 GREAT VALLEY PKWY. | MALVERN | PA | 19355 |
| K170844 | Osseus Fusion Systems, LLC |
2703 Mockingbird Lane, Suite 102 | Dallas | TX | 75235 |
| K143572 | Osteomed Implantes, LTDA |
Washington Luiz Road, km 172, Condominio Conpark - Rua 6 | Rio Claro | 13501-600 | |
| K220261 | Paonan Biotech Co., Ltd. |
3F, No.50, Lane 258, Rueiguang Road, Neihu District | Taipei City | 114062 | |
| K213493 | Paradigm Spine |
Eisenbahnstrabe 84 | Wurmlingen Baden-Wurttemberg | 78573 | |
| K140066 | PINNACLE SPINE GROUP, LLC |
1601 Elm St Ste 1930 | Dallas | TX | 75201 |
| K133623 | PIONEER SURGICAL TECHNOLOGY, INC |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855 |
| K142041 | POROSTEON, INC. |
100 PROMENADE SAINT LOUIS | NOTRE-DAME-DE-L'LLE-PERROT,QUEBEC | J7V 7P2 | |
| K172568 | PRECIFIT MEDICAL LTD |
2233 5th Street East | St. Paul | MN | 55119 |
| K161809 | Precision Spine, Inc. |
2050 Executive Drive | Pearl | MS | 39208 |
| K161642 | PROVIDENCE MEDICAL TECHNOLOGY, INC |
1331 N. CALIFORNIA BLVD., SUITE 320 | WALNUT CREEK | CA | 94596 |
| K122801 | PROVIDENCE MEDICAL TECHNOLOGY, INC. |
3650 MT Diablo Blvd Ste 104 | Lafayette | CA | 94549 |
| K112801 | QUALGENIX |
1 JACK'S HILL ROAD | OXFORD | CT | 06478 |
| K120396 | Reliance Medical Systems, LLC |
545 SOUTH 500 WEST | BOUNTIFUL | UT | 84010 |
| K173102 | Reliance Medical Systems, LLC |
545 West 500 South | Bountiful | UT | 84010 |
| K142269 | Reliance Medical Systems, LLC |
545 West 500 South, Suite 100 | Bountiful | UT | 84010 |
| K172489 | Reliance Medical Systems, LLC |
545 West 500 South, Suite 100 | Bountiful | UT | 84010 |
| K202266 | Reliance Medical Systems, LLC |
545 West 500 South, Suite 100 | Bountiful | UT | 84010 |
| K131429 | Reliance Medical Systems, LLC |
P.O. BOX 1693 | BOUNTIFUL | UT | 84011 |
| K190889 | Republic Spine, L.L.C. |
2424 N. Federal Hwy | Boca Raton | FL | 33431 |
| K150455 | RHAUSLER, INC. |
837 INDUSTRIAL ROAD | SAN CARLOS | CA | 94070 |
| K092540 | RSB SPINE LLC. |
8202 SHERMAN ROAD | CHESTERLAND | OH | 44026-2141 |
| K163673 | RTI Surgical, Inc. |
11621 Research Circle | Alachua | FL | 32615 |
| K150521 | RTI SURGICAL, INC. dba RTI BIOLOGICS |
11621 Research Cir | ALACHUA | FL | 32615 |
| K192316 | Sapphire Medical Group |
32565 B Golden Lantern Street, Suite 113 | Dana Point | CA | 92629 |
| K172674 | Sapphire Medical Group |
32565 B Golden Lantern | Dana Point | CA | 92629 |
| K220296 | SeaSpine Orthopedics Corporation |
5770 Armada Drive | Carlsbad | CA | 92008 |
| K171046 | SeaSpine Orthopedics Corporation |
5770 Armada Drive | Carlsbad | CA | 92008 |
| K172926 | SeaSpine Orthopedics Corporation |
5770 Armada Drive | Carlsbad | CA | 92008 |
| K183083 | SeaSpine Orthopedics Corporation |
5770 Armada Drive | Carlsbad | CA | 92008 |
| K082309 | SEASPINE, INC. |
2302 LA MIRADA DR. | VISTA | CA | 92081-7862 |
| K163422 | SHANGHAI SANYOU MEDICAL CO, LTD |
1988 JIATANG ROAD | JIADIANG DISTRICT | 201807 | |
| K082848 | SIGNUS MEDIZINTECHNIK GMBH |
8202 SHERMAN ROAD | CHSETERLAND | OH | 44026 |
| K182608 | Silony Medical GmbH |
Leinfelder Stra▀e 60 | Leinfelden-Echterdingen | d-70771 | |
| K162587 | SILONY MEDICAL GMBH |
LEINFELDER STRASSE 60 | Leinfelden-Echterdingen | 70771 | |
| K192044 | Solco Biomedical Co., Ltd. |
154 Seotan-ro, Seotan-myeon | Pyeongtaek-Si | 17704 | |
| K162402 | SOLCO BIOMEDICAL CO., LTD. |
154 SEOTAN-RO, SEOTAN-MYEON | PYEONGTAEK | 17704 | |
| K230607 | Southern Medical (Pty) Ltd |
Building 10, Southern Implants Office Park | Irene | 0062 | |
| K130948 | SOUTHERN SPINE, LLC |
111 LAUREL RIDGE DRIVE | ALPHARETTA | GA | 30004 |
| K083167 | SPINAL DEVICES, LLC |
13540 GUILD AVE | APPLE VALLEY | MN | 55124 |
| K073351 | SPINAL ELEMENTS, INC. |
2744 LOKER AVE. W. SUITE 100 | CARLSBAD | CA | 92010 |
| K222833 | Spinal Elements, Inc. |
3115 Melrose Dr., Suite 200 | Carlsbad | CA | 92010 |
| K083118 | SPINAL USA |
2050 EXECUTIVE DR. | PEARL | MS | 39208 |
| K073320 | SPINE SMITH PARTNERS L.P. |
5300 NORTH LAMAR BLVD #107 | AUSTIN | TX | 78751 |
| K172065 | SPINEART |
3 chemin du pre Fleuri | Plan Les Ouates | 1228 | |
| K190322 | Spineart |
3 chemin du pre Fleuri | Plan Les Ouates | 1228 | |
| K091873 | SPINEART |
COINTRIN 20 ROUTE DE PRE-BOIS | GENEVA | 1215 | |
| K122366 | SPINEART |
COINTRIN 20 ROUTE DE PRE-BOIS | GENEVA | 1215 | |
| K200312 | Spineart |
3 Chemin du pre Fleuri | Plan Les Ouates | 1228 | |
| K230583 | Spineart SA |
3 Chemin du Pre-Fleuri | Plan-les-Ouates | 1228 | |
| K090887 | SPINECRAFT |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681 |
| K211935 | SpineCraft, LLC |
777 Oakmont Lane, Suite 200 | Westmont | IL | 60559 |
| K141337 | SPINEFRONTIER, INC. |
4628 NORTHPARK DRIVE | COLORADO SPRINGS | CO | 80918 |
| K141333 | SPINEFRONTIER, INC. |
4628 NORTHPARK DRIVE | COLORADO SPRINGS | CO | 80918 |
| K113518 | SPINEFRONTIER, INC. |
500 CUMMINGS CENTER | BEVERLY | MA | 01915 |
| K142026 | SPINEFRONTIER, INC. |
4628 NORTHPARK DRIVE | COLORADO SPRINGS | CO | 80918 |
| K110733 | SPINENET, LLC |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K162694 | Spineway |
7 Allee Moulin Berger Ecully France 69130 | Ecully | 69130 | |
| K142251 | Stryker Corporation |
2 Pearl Court | Allendale | NJ | 07401 |
| K152532 | STRYKER SPINE |
2 PEARL COURT | ALLENDALE | NJ | 07401 |
| K161407 | Stryker Spine |
2 Pearl Court | Allendale | NJ | 07401 |
| K120486 | STRYKER SPINE |
2 PEARL COURT | ALLENDALE | NJ | 07401 |
| K171496 | STRYKER SPINE |
2 Pearl Court | Allendale | NJ | 07401 |
| K221490 | Stryker Spine |
2 Pearl Court | Allendale | NJ | 07401 |
| K163494 | Summit Spine |
2333 Airport Rd. | Georgetown | TX | 78628 |
| K120275 | SYNTHES (USA) LLC |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K162003 | The Institute of Musculoskeletal Science & Education |
418 E. Lancaster Ave | Wayne | PA | 19087 |
| K160222 | THE ORTHOPAEDIC IMPLANT COMPANY |
316 CALIFORNIA AVE | RENO | NV | 89509 |
| K111675 | THEKEN SPINE LLC |
1153 MEDINA RD. | MEDINA | OH | 44256-0000 |
| K192018 | Titan Spine, Inc |
6140 West Executive Dr., Suite A | Mequon | WI | 53092 |
| K183557 | Titan Spine, Inc |
6140 W. Executive Dr., Suite A | Mequon | WI | 53092 |
| K100889 | TITAN SPINE, LLC |
555 13TH ST, NW | WASHINGTON | DC | 20004 |
| K173535 | Titan Spine, LLC |
6140 W. Executive Dr., Suite A | Mequon | WI | 53092 |
| K092794 | TRANSCORP, INC. |
1000 100TH ST. SW, SUITE F | BYRON CENTER | MI | |
| K121178 | TRANSCORP, INC. |
1000 100TH ST. SW, SUITE F | BYRON CENTER | MI | 49315 |
| K130573 | TYBER MEDICAL LLC |
89 HEADQUARTERS PLAZA NORTH | MORRISTOWN | NJ | 07960 |
| K182284 | Tyber Medical LLC |
83 South Commerce Way, Suite 310 | Bethlehem | PA | 18017 |
| K172185 | Tyber Medical LLC |
83 South Commerce Way, | Bethlehem | PA | 18017 |
| K180590 | Tyber Medical, LLC |
83 South Commerce Way | Bethlehem | PA | 18017 |
| K132926 | U&I CORP. |
20, Sandan-ro 76beon-gil(Rd) | Uijeongbu-si | 480-859 | |
| K140864 | U&I CORP. |
20, Sandan-ro 76beon-gil(Rd) | Uijeongbu-si | 480-859 | |
| K190067 | U&i Corporation |
20, Sandan-ro 76beon-gil(Rd) | Uijeongbu-si | 11781 | |
| K171749 | U&i Corporation |
20, Sandan-ro 76beon-gil(Rd) | Uijeongbu-si | 11781 | |
| K220696 | Ulrich Medical USA |
18221 Edison Avenue | Chesterfield | MO | 63005 |
| K082801 | US SPINE |
3600 FAU BLVD. | BOCA RATON | FL | 33431 |
| K143685 | Vertera, Inc. |
311 Ferst Drive NW, Suite L1328 | Atlanta | GA | 30332 |
| K230414 | Vy Spine, LLC |
2236 Capital Circle NE, Suite 103-1 | Tallahassee | FL | 32308 |
| K221162 | Vy Spine, LLC |
2236 Capital Circle NE, Suite 103-1 | Tallahassee | FL | 32308 |
| K223513 | Vy Spine, LLC |
2236 Capital Circle NE, Suite 103-1 | Tallahassee | FL | 32308 |
| K212715 | Vy Spine, LLC |
2236 Capital Circle NE, Suite 103-1 | Tallahassee | FL | 32308 |
| K120603 | WENZEL SPINE |
206 Wild Basin Road | Austin | TX | 78746 |
| K111123 | WENZEL SPINE |
1001 OAKWOOD BLVD | ROUND ROCK | TX | 78681 |
| K231076 | Wenzel Spine, Inc. |
1130 Rutherford Lane | Austin | TX | 78753 |
| K112036 | X-SPINE SYSTEMS, INC |
452 Alexandersville Rd | Miamisburg | OH | 45342 |
| K083637 | X-SPINE SYSTEMS, INC. |
452 ALEXANDERSVILLE RD. | MIAMISBURG | OH | 45342 |
| K171075 | X-Spine Systems, Inc. |
452 Alexandersville Rd | Miamisburg | OH | 45342 |
| K173832 | X-Spine Systems, Inc. |
452 Alexandersville Rd. | Miamisburg | OH | 45342 |
| K140786 | XENCO MEDICAL, LLC |
9930 MESA RIM DRIVE | SAN DIEGO | CA | 92121 |
| K152302 | Xenco Medical, LLC |
9930 Mesa Rim Road | San Diego | CA | 92121 |
| K152987 | XENCO MEDICAL, LLC |
9930 MESA RIM ROAD | SAN DIEGO | CA | 92121 |
| K112664 | ZAVATION LLC |
501 AVALON WAY | BRANDON | MS | 39047 |
| K191354 | Zavation Medical Products, LLC |
220 Lakeland Parkway | Flowood | MS | 39232 |
| K202398 | Zavation Medical Products, LLC |
220 Lakeland Parkway | Flowood | MS | 39232 |
| K111119 | ZIMMER SPINE, INC |
12708 RIATA VISTA CIRCLE | AUSTIN | TX | 78727 |
| K103033 | ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. | PARSIPPANY | NJ | 07054 |
| K111983 | ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. | PARSIPPANY | NJ | 07054 |
| K133784 | ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. | PARSIPPANY | NJ | 07054 |
| K202488 | ZSFab Inc. |
705 Cambridge Street STE 1 | Cambridge | MA | 02141 |
| K232150 | ZSFab Inc. |
96 Clematis Ave, Suite 2F | Walthan | MA | 02453 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
