FDA 510(k) Applications for Medical Device:
Spinal Vertebral Body Replacement Device
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K083186 | AESCULAP IMPLANT SYSTEM, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K142150 | AESCULAP IMPLANT SYSTEM, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K133802 | AESCULAP IMPLANT SYSTEM, INC. |
3773 CORPORATE PWKY. | CENTER VALLEY | PA | 18034 |
| K110864 | AESCULAP IMPLANT SYSTEMS, LLC |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K060762 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K232173 | Alphatec Spine, Inc. |
1950 Camino Vida Roble | Carlsbad | CA | 92008 |
| K080699 | ALPHATEC SPINE, INC. |
2051 PALOMAR AIRPORT ROAD | CARLSBAD | CA | 92011 |
| K042201 | ALPHATEC/NEXMED |
6110 CORTE DEL CEDRO | CARLSBAD | CA | 92009 |
| K050553 | ALPHATEC/NEXMED |
6110 CORTE DEL CEDRO | CARLSBAD | CA | 92009 |
| K051525 | AMEDICA CORP. |
615 ARAPEEN DRIVE | SALT LAKE CITY | UT | 84108 |
| K073505 | AMEDICA CORP. |
1331 H ST. NW, 12TH FLOOR | WASHINGTON | DC | 20005 |
| K073125 | AMEDICA CORP. |
1331 H ST. NW, 12TH FLOOR | WASHINGTON | DC | 20005 |
| K152460 | Amendia, Inc. |
1755 West Oak Parkway | Marietta | GA | 30062 |
| K211892 | ARFTX Medical LLC |
50 Laura Street #2524 | Jacksonville | FL | 32202 |
| K063464 | ATLAS SPINE INC. |
1555 JUPITER PARK DR., STE. 4 | JUPITER | FL | 33458 |
| K071497 | ATLAS SPINE INC. |
1555 JUPITER PARK DR., STE. 4 | JUPITER | FL | 33458 |
| K091406 | ATLAS SPINE LLC |
1555 JUPITER PARK DR., STE. 4 | JUPITER | FL | 33458 |
| K063205 | ATLAS SPINE LLC |
11234 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
| K063393 | BIOMET SPINE |
P.O. BOX 587 | WARSAW | IN | 46581-0587 |
| K033702 | BLACKSTONE MEDICAL, INC. |
90 BROOKSDALE DR. | SPRINGFIELD | MA | 01104 |
| K041939 | BLACKSTONE MEDICAL, INC. |
90 BROOKDALE DR. | SPRINGFIELD | MA | 01104 |
| K030744 | BLACKSTONE MEDICAL, INC. |
90 BROOKSDALE DR. | SPRINGFIELD | MA | 01104 |
| K032700 | BLACKSTONE MEDICAL, INC. |
90 BROOKSDALE DR. | SPRINGFIELD | MA | 01104 |
| K051246 | BLACKSTONE MEDICAL, INC. |
90 BROOKSDALE DR. | SPRINGFIELD | MA | 01104 |
| K060350 | BLACKSTONE MEDICAL, INC. |
1211 HAMBURG TURNPIKE | WAYNE | NJ | 07470 |
| K172330 | Blustone Synergy |
5520 Ventana Ct. | Pueblo | CO | 81005 |
| K143490 | CAMBER SPINE |
418 E. Lancaster Ave. | Wayne | PA | 19087 |
| K173800 | Camber Spine Technologies |
418 E. Lancaster Avenue | Wayne | PA | 19087 |
| K192214 | CarboFix Orthopedics Ltd. |
11 Ha'hoshlim St. | Herzeliya | 4672411 | |
| K121176 | CARDINAL SPINE, LLC |
11234 EL CAMINO REAL, | SAN DIEGO | CA | 9213 |
| K142030 | CARDINAL SPINE, LLC |
12264 EL CAMINO REAL, | SAN DIEGO | CA | 92130 |
| K183588 | Choice Spine |
400 Erin Drive | Knoxville | TN | 37919 |
| K171686 | Choice Spine |
400 Erin Drive | Knoxville | TN | 37924 |
| K120570 | CHOICE SPINE, LP |
400 Erin Dr | KNOXVILLE | TN | 37919 |
| K190349 | CMF Medicon Surgical Inc. |
11200 St. Johns Industrial Pkwy N, Suite 1 | Jacksonville | FL | 32246 |
| K072326 | CO-LIGNE AG |
1070 CONRAD AVENUE, SUITE 230 | CONCORD | CA | 94520 |
| K202637 | CoreLink, LLC |
2072 Fenton Logistics Park Blvd. | St.Louis | MO | 63026 |
| K080860 | CREASPINE |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K081564 | CREASPINE |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
| K072537 | CREASPINE SAS |
49 PLAIN STREET | NORTH ATTLEBORO | MA | 02760 |
| K030833 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K031635 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K023835 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K020522 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K013382 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K001340 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K003043 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K030249 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K990148 | DEPUY MOTECH ACROMED |
325 PARAMOUNT DR. | RAYHAM | MA | 02767-0350 |
| K073649 | DEPUY SPINE, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K052746 | DEPUY SPINE, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K041722 | DEPUY SPINE, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K080568 | DEPUY SPINE, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K183054 | DePuy Synthes Spine |
325 Paramount Drive | Raynham | MA | 02767 |
| K092336 | EBI, L.P. |
399 JEFFERSON ROAD | PARSIPPANY | NJ | 07054 |
| K020887 | EBI, L.P. |
399 JEFFERSON ROAD | PARSIPPANY | NJ | 07054 |
| K042268 | EBI, L.P. |
399 JEFFERSON ROAD | PARSIPPANY | NJ | 07054 |
| K061016 | EBI, L.P. |
399 JEFFERSON ROAD | PARSIPPANY | NJ | 07054 |
| K040482 | EBI, L.P. |
399 JEFFERSON ROAD | PARSIPPANY | NJ | 07054 |
| K062810 | EBI, L.P. |
399 JEFFERSON ROAD | PARSIPPANY | NJ | 07054 |
| K112429 | EDEN SPINE, LLC |
13540 GUILD AVE | APPLE VALLEY | MN | 55124 |
| K032371 | ENCORE MEDICAL, L.P. |
9800 METRIC BLVD. | AUSTIN | TX | 78758 |
| K050997 | FLEXUSPINE, INC. |
120 W. FIFTH STREET, SUITE 200 | TYLER | TX | 75701 |
| K190147 | Globus Medical Inc. |
2560 General Armistead Ave. | Audubon | PA | 19403 |
| K162315 | GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K173982 | Globus Medical Inc. |
2560 General Armistead Ave. | Audubon | PA | 19403 |
| K072465 | GLOBUS MEDICAL INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K031302 | GLOBUS MEDICAL INC. |
303 SCHELL LN. | PHOENIXVILLE | PA | 19460 |
| K050850 | GLOBUS MEDICAL INC. |
303 SCHELL LN. | PHOENIXVILLE | PA | 19460 |
| K060665 | GLOBUS MEDICAL INC. |
303 SCHELL LN. | PHOENIXVILLE | PA | 19460 |
| K121107 | GLOBUS MEDICAL, INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K112756 | GLOBUS MEDICAL, INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K061380 | GLOBUS MEDICAL, INC. |
303 SCHELL LANE | PHOENIXVILLE | PA | 19460 |
| K040284 | GLOBUS MEDICAL, INC. |
303 SCHELL LANE | PHOENIXVILLE | PA | 19460 |
| K071274 | GOLD STANDARD ORTHOPEDICS LLC |
1226 ROWAN ST. | LOUISVILLE | KY | 40203 |
| K033837 | HOWMEDICA OSTEONICS CORP. |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K200235 | icotec ag |
Industriestrasse 12 | Altstaetten | 9450 | |
| K032527 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K031823 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K010378 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K021967 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K022563 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K021025 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K051978 | IMPLEX CORP. |
80 COMMERCE DR. | ALLENDALE | NJ | 07401-1600 |
| K051196 | IMPLEX CORP. |
80 COMMERCE DRIVE | ALLENDALE | NJ | 07401-1600 |
| K062151 | INNOVASIS, INC. |
614 EAST 3900 SOUTH | SALT LAKE CITY | UT | 84107 |
| K062759 | INNOVATIVE SPINAL TECHNOLOGIES INC |
111FORBES BLVD | MANSFIELD | MA | 02048 |
| K091743 | INNVOTEC SURGICAL, INC. |
1331 H STREET NW | WASHINGTON | DC | 20005 |
| K040928 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K010530 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K022143 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K020048 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K040168 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K014145 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K050861 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K020204 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K010989 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K041407 | INTERPORE CROSS INTL. |
181 TECHNOLOGY DR. | IRVINE | CA | 92618-2402 |
| K983667 | IONICS MEDICAL CORP. |
702 13TH ST., #108 | MIAMI BEACH | FL | 33139 |
| K170055 | K2M |
600 Hope Parkway SE | Leesburg | VA | 20175 |
| K171704 | K2M |
600 Hope Parkway SE | Leesburg | VA | 20175 |
| K063399 | K2M, INC. |
751 MILLER DR.,SE | LEESBURG | VA | 20175 |
| K080024 | K2M, INC. |
751 MILLER DR. SE, SUITE F1 | LEESBURG | VA | 20175 |
| K142016 | K2M, INC. |
751 MILLER DR.,SE | LEESBURG | VA | 20175 |
| K111294 | K2M, INC. |
751 MILLER DR.,SE | LEESBURG | VA | 20175 |
| K051454 | K2M, LLC |
751 MILLER DR.,S.E., SUITE F1 | LEESBURG | VA | 20175 |
| K180665 | K2M, LLC. |
600 Hope Parkway SE | Leesburg | VA | 20175 |
| K110153 | KONIGSEE IMPLANTATE GMBH |
1331 H STREET NW, 12TH FLOOR | WASHINGTON | DC | 20005 |
| K052384 | LANX, LLC |
200 GREGORY LANE | PLEASANT HILL | CA | 94523-3389 |
| K080572 | LDR SPINE USA |
4030 WEST BRAKER LANE | AUSTIN | TX | 78759 |
| K080728 | LDR SPINE USA |
4030 WEST BRAKER LANE | AUSTIN | TX | 78759 |
| K083857 | LDR SPINE USA |
4030 WEST BRAKER LANE | AUSTIN | TX | 78759 |
| K080569 | LDR SPINE USA |
4030 WEST BRAKER LANE | AUSTIN | TX | 78759 |
| K072132 | LDR SPINE USA |
4030 WEST BRAKER LANE | AUSTIN | TX | 78759 |
| K043479 | LDR SPINE USA |
4030 WEST BRAKER LANE | AUSTIN | TX | 78759 |
| K043349 | LDR SPINE USA |
4030 WEST BRAKER LANE | AUSTIN | TX | 78759 |
| K162133 | LDR SPINE USA, INC. |
13785 RESEARCH BLVD | AUSTIN | TX | 78750 |
| K122622 | LUCERO MEDICAL, LLC |
33490 PIN OAK PARKWAY | AVON LAKE | OH | 44012 |
| K093207 | LUCERO MEDICAL, LLC |
PO BOX 67 | RICHFIELD | OH | 44286 |
| K173787 | Medos International SARL |
Chemin-Blanc 38 | Le Locle | 2400 | |
| K051105 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K033926 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K040422 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K023570 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K040536 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K041197 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K041452 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K041556 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K043561 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K043566 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K052931 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K060719 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K030735 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K063491 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K173125 | Medtronic Sofamor Danek |
1800 Pyramid Place | Memphis | TX | 38132 |
| K071033 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K082112 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K021791 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K030601 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K031780 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K040167 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K062073 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K062427 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K030736 | MEDTRONIC SOFAMOR DANEK |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K052261 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K183197 | Medtronic Sofamor Danek USA, INC. |
1800 Pyramid Pl. | Memphis | TN | 38132 |
| K091883 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K100976 | MEDTRONIC SOFAMOR DANEK USA, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K010930 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K011406 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K131888 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K024049 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K061938 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K070173 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K183510 | Medtronic Sofamor Danek, USA Inc. |
1800 Pyramid Place | Memphis | TN | 38132 |
| K181328 | Medtronic Sofamor Danek, USA Inc. |
1800 Pyramid Place | Memphis | TN | 38132 |
| K062133 | MEDTRONIC SPINAL AND BIOLOGICS DIV |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K072029 | NEW BUSINESS DEVELOPMENT, LLC |
1155 ALLGOOD RD. | MARIETTA | GA | 30062 |
| K193506 | NuVasive Incorporated |
7475 Lusk Boulevard | San Diego | CA | 92121 |
| K090176 | NUVASIVE, INC. |
7475 LUSK BLVD | SAN DIEGO | CA | 92121 |
| K052210 | NUVASIVE, INC. |
4545 TOWNE CENTRE COURT | SAN DIEGO | CA | 92121 |
| K043405 | NUVASIVE, INC. |
4545 TOWNE CENTRE COURT | SAN DIEGO | CA | 92121 |
| K023319 | NUVASIVE, INC. |
10065 OLD GROVE RD. | SAN DIEGO | CA | 92131 |
| K032476 | NUVASIVE, INC. |
10065 OLD GROVE RD. | SAN DIEGO | CA | 92131 |
| K142205 | NUVASIVE, INC. |
7475 LUSK BLVD. | SAN DIEGO | CA | 92121 |
| K140563 | NUVASIVE, INCORPORATED |
7475 LUSK BLVD | SAN DIEGO | CA | 92121 |
| K151538 | NuVasive, Incorporated |
7475 Lusk Blvd. | San Diego | CA | 92121 |
| K151167 | NUVASIVE, INCORPORATED |
7475 LUSK BLVD. | SAN DIEGO | CA | 92121 |
| K170271 | NuVasive, Incorporated |
7475 Lusk Boulevard | San Diego | CA | 92121 |
| K172323 | Omnia Medical, LLC |
1000 Hampton Center | Morgantown | WV | 26505 |
| K062666 | ORTHO DEVELOPMENT CORP. |
12187 SOUTH BUSINESS PARK DR. | DRAPER | UT | 84020 |
| K032812 | ORTHOVITA, INC. |
45 GREAT VALLEY PKWY. | MALVERN | PA | 19355 |
| K053080 | OSTEOTECH, INC. |
51 JAMES WAY | EATONTOWN | NJ | 07724 |
| K051781 | OSTEOTECH, INC. |
51 JAMES WAY | EATONTOWN | NJ | 07724 |
| K012254 | OSTEOTECH, INC. |
51 JAMES WAY | EATONTOWN | NJ | 07724 |
| K003155 | OSTEOTECH, INC. |
51 JAMES WAY | EATONTOWN | NJ | 07724 |
| K142005 | OXFORD PERFORMANCE MATERIALS |
30 S SATELLITE ROAD | SOUTH WINDSOR | CT | 06074 |
| K043206 | PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855-0627 |
| K061151 | PIONEER SURGICAL TECHNOLOGY |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855-0627 |
| K131724 | PIONEER SURGICAL TECHNOLOGY, INC |
375 RIVER PARK CIRCLE | MARQUETTE | MI | 49855 |
| K062004 | QUANTUM ORTHOPEDICS, INC. |
2744 LOKER AVE. W. SUITE 100 | CARLSBAD | CA | 92008 |
| K061576 | QUANTUM ORTHOPEDICS, INC. |
2744 LOKER AVE. W. SUITE 100 | CARLSBAD | CA | 92008 |
| K052641 | QUANTUM ORTHOPEDICS, INC. |
2744 LOKER AVE. W. SUITE 100 | CARLSBAD | CA | 92008 |
| K050449 | QUANTUM ORTHOPEDICS, INC. |
2744 LOKER AVE. W. SUITE 100 | CARLSBAD | CA | 92008 |
| K063637 | Reliance Medical Systems, LLC |
1838 E 9800 SOUTH | SANDY | UT | 84092 |
| K081383 | Reliance Medical Systems, LLC |
2647 CASSOWARY CIR | SANDY | UT | 84092-7116 |
| K061401 | RSB SPINE LLC. |
8202 SHERMAN ROAD | CHESTERLAND | OH | 44026 |
| K070316 | RSB SPINE LLC. |
8202 SHERMAN ROAD | CHESTERLAND | OH | 44026 |
| K071372 | RSB SPINE LLC. |
8202 SHERMAN ROAD | CHESTERLAND | OH | 44026 |
| K050348 | SCIENT'X |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681 |
| K033109 | SCIENT'X |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681 |
| K053292 | SCIENT'X USA, INC. |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681 |
| K052170 | SEASPINE, INC. |
2303 LA MIRADA DR. | VISTA | CA | 92081-7862 |
| K071726 | SEASPINE, INC. |
2302 LA MIRADA DR. | VISTA | CA | 92081-7862 |
| K052096 | SIGNUS MEDICAL LLC. |
4050 OLSON MEMORIAL HIGHWAY | MINNEAPOLIS | MN | 55422 |
| K031757 | SIGNUS MEDICAL LLC. |
4050 OLSON MEMORIAL HIGHWAY | MINNEAPOLIS | MN | 55422 |
| K022793 | SIGNUS MEDICAL LLC. |
4050 OLSON MEMORIAL HIGHWAY | MINNEAPOLIS | MN | 55422 |
| K081332 | SIGNUS MEDIZINTECHNIK GMBH |
8202 SHERMAN ROAD | CHSETERLAND | OH | 44026 |
| K041888 | SIGNUS MEDIZINTECHNIK GMBH |
5050 OLSON MEMORIAL HWY | MINNEAPOLIS | MN | 55422 |
| K080349 | SIGNUS MEDIZINTECHNIK GMBH |
4050 OLSON MEMORIAL HWY | MINNEAPOLIS | MN | 55422 |
| K052533 | SIGNUS MEDIZINTECHNIK GMBH |
4050 OLSON MEMORIAL HWY | MINNEAPOLIS | MN | 55422 |
| K061082 | SIGNUS MEDIZINTECHNIK GMBH |
4050 OLSON MEMORIAL HWY | MINNEAPOLIS | MN | 55422 |
| K043316 | SIGNUS MEDIZINTECHNIK GMBH |
4050 OLSON MEMORIAL HWY | MINNEAPOLIS | MN | 55422 |
| K051659 | SIGNUS MEDIZINTECHNIK GMBH |
4050 OLSON MEMORIAL HWY | MINNEAPOLIS | MN | 55422 |
| K123758 | SIGNUS MEDIZINTECHNIK GMBH |
PO BOX 566 | CHESTERLAND | OH | 44026-2141 |
| K070181 | SINTEA BIOTECH, INC. |
407 LINCOLN RD. SUITE 10L | MIAMI BEACH | FL | 33139 |
| K101886 | SINTEA PLASTEK, LLC |
407 LINCOLN ROAD | MIAMI BEACH | FL | 33139 |
| K061578 | SPECIALTY SPINE PRODUCTS, LLC |
11234 EL CAMINO REAL | SAN DIEGO | CA | 92130 |
| K051000 | SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F | AUSTIN | TX | 78727 |
| K033517 | SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F | AUSTIN | TX | 78727 |
| K033663 | SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F | AUSTIN | TX | 78727 |
| K031914 | SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F | AUSTIN | TX | 78727 |
| K031672 | SPINAL CONCEPTS, INC. |
5301 RIATA PARK CT., BLDG. F | AUSTIN | TX | 78727 |
| K060916 | SPINAL EDGE, LLC |
25125 DETROIT ROAD | WESTLAKE | OH | 44145 |
| K061752 | SPINAL USA |
644 LAKELAND EAST DR., STE. A | FLOWOOD | MS | 39232 |
| K042714 | SPINE NEXT AMERICA CORPORATION |
8381 DIX ELLIS TRAIL, STE. 110 | JACKSONVILLE | FL | 32256 |
| K042713 | SPINE NEXT AMERICA CORPORATION |
8381 DIX ELLIS TRAIL, STE. 110 | JACKSONVILLE | FL | 32256 |
| K080971 | SPINE SMITH PARTNERS L.P. |
8140 N. MOPAC | AUSTIN | TX | 78759 |
| K101288 | SPINE WAVE, INC. |
THREE ENTERPRISE DR. | SHELTON | CT | 06484 |
| K121889 | SPINE WAVE, INC. |
THREE ENTERPRISE DR. | SHELTON | CT | 06484 |
| K052670 | SPINE WAVE, INC. |
TWO ENTERPRISE DR. | SHELTON | CT | 06484 |
| K090315 | SPINE WAVE, INC. |
TWO ENTERPRISE DR. | SHELTON | CT | 06484 |
| K102315 | SPINE WAVE, INC. |
THREE ENTERPRISE DR. | SHELTON | CT | 06484 |
| K133207 | SPINE WAVE, INC. |
THREE ENTERPRISE DR. | SHELTON | CT | 06484 |
| K102682 | SPINE WAVE, INC. |
3 ENTERPRISE DR | SHELTON | CT | 06484 |
| K111418 | SPINE WAVE, INC. |
3 ENTERPRISE DR | SHELTON | CT | 06484 |
| K142996 | SPINE WAVE, INC. |
3 ENTERPRISE DRIVE | SHELTON | CT | 06484 |
| K111469 | SPINE WAVE, INC. |
3 ENTERPRISE DR | SHELTON | CT | 06484 |
| K042930 | SPINEVISION, INC. |
3003 SUMMIT BLVD. STE 1400 | ATLANTA | GA | 30319 |
| K042600 | SPINEWORKS, LLC |
555 13TH STREET N.W. | WASHINGTON | DC | 20004 |
| K061836 | STRYKER SPINE |
2 PEARL COURT | ALLENDALE | NJ | 07401 |
| K062132 | STRYKER SPINE |
2 PEARL COURT | ALLENDALE | NJ | 07401 |
| K051205 | STRYKER SPINE |
2 PEARL CT. | ALLENDALE | NJ | 07401-1677 |
| K050624 | STRYKER SPINE |
2 PEARL COURT | ALLENDALE | NJ | 07401 |
| K042571 | STRYKER SPINE |
2 PEARL COURT | ALLENDALE | NJ | 07401 |
| K040731 | STRYKER SPINE |
2 PEARL COURT | ALLENDALE | NJ | 07401 |
| K060506 | STRYKER SPINE |
2 PEARL COURT | ALLENDALE | NJ | 07401 |
| K091946 | STRYKER SPINE |
2 PEARL COURT | ALLENDALE | NJ | 07401 |
| K041617 | SURGICRAFT LTD. |
121 W. CHESTNUT ST., #3506 | CHICAGO | IL | 60610 |
| K051027 | SURGICRAFT LTD. |
950 N MICHIGAN AVE. #2202 | CHICAGO | IL | 60611 |
| K003836 | SYNTHES |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K003275 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K020152 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K024364 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K011037 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K041389 | SYNTHES SPINE |
1230 WILSON DRIVE | WEST CHESTER | PA | 19380 |
| K061891 | SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K062083 | SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K053508 | SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K062933 | SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K103320 | SYNTHES SPINE CO.LP |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K070381 | THEKEN SPINE LLC |
283 E WATERLOO RD. | AKRON | OH | 44319 |
| K071031 | THEKEN SPINE LLC |
283 E WATERLOO RD. | AKRON | OH | 44319 |
| K070786 | THEKEN SPINE LLC |
283 E WATERLOO RD. | AKRON | OH | 44319 |
| K032064 | THEKEN SURGICAL,LLC |
283 E WATERLOO RD. | AKRON | OH | 44319 |
| K050058 | THEKEN SURGICAL,LLC |
283 E WATERLOO RD. | AKRON | OH | 44319 |
| K041798 | U.S. SPINAL TECHNOLOGIES, LLC. |
PO BOX 560 | STILL WATER | MN | 55082 |
| K090841 | ULRICH GMBH & CO. KG |
754 SPIRIT 40 PARK DRIVE | CHESTERFIELD | MO | 63005 |
| K060416 | ULRICH GMBH & CO. KG |
2519 MCMULLEN BOOTH ROAD | CLEARWATER | FL | 33759 |
| K192117 | ulrich GmbH & Co. KG |
Buchbrunnenweg 12 | Ulm | 89081 | |
| K181921 | ulrich medical USA |
18221 Edison Avenue | Chesterfield | MO | 63005 |
| K003709 | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
150 GLOVER AVE. | NORWALK | CT | 06856 |
| K070082 | VERTEBRATION,INC |
310 TERRACE AVENUE, SUITE 201 | CINCINNATI | OH | 45220 |
| K082466 | VERTEBRATION,INC |
310 TERRACE AVENUE, SUITE 201 | CINCINNATI | OH | 45220 |
| K073502 | VERTEBRON, INC. |
80 HATHAWAY DRIVE | STRATFORD | CT | 06615 |
| K091426 | VERTICOR, LTD |
1001 OAKWOOD BLVD. | ROUND ROCK | TX | 78681 |
| K070218 | VERTIFLEX (TM), INCORPORATED |
1954 KELLOGG AVENUE, SUITE 100 | CARLSBAD | CA | 92008 |
| K052950 | ZIMMER TRABECULAR |
80 COMMERCE DR. | ALLENDALE | NJ | 07401 |
| K061155 | ZIMMER TRABECULAR |
80 COMMERCE DR. | ALLENDALE | NJ | 07401 |
| K093127 | ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. | PARSIPPANY | NJ | 07054 |
| K070754 | ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. | PARSIPPANY | NJ | 07054 |
| K070382 | ZIMMER TRABECULAR METAL TECHNOLOGY |
10 POMEROY RD. | PARSIPPANY | NJ | 07054 |
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