FDA 510(k) Applications for Medical Device:
System, Facet Screw Spinal Device
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K123218 | ALPHATEC SPINE, INC. |
5830 EL CAMINO REAL | CARLSBAD | CA | 92008 |
| K110170 | ALPHATEC SPINE, INC. |
5818 EL CAMINO REAL | CARLSBAD | CA | 92008 |
| K092568 | AMENDIA, INC. |
13540 GUILD AVENUE | APPLE VALLEY | MN | 55124 |
| K113011 | AMENDIA, INC. |
13540 GUILD AVENUE | APPLE VALLEY | MN | 55124 |
| K120340 | APOLLO SPINE, INC. |
75 MILL STREET | STOUGHTON | MA | 02072 |
| K250920 | Arthrex, Inc. |
1370 Creekside Blvd. | Naples | FL | 34108 |
| K243865 | Aurora Spine |
1930 Palomar Point Way Suite 103 | Carlsbad | CA | 92009 |
| K121850 | CHOICE SPINE, LP |
400 Erin Dr | KNOXVILLE | TN | 37919 |
| K120597 | CUSTOM SPINE, INC. |
9 Campus Dr | PARSIPPANY | NJ | 07054 |
| K012773 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K101762 | DEPUY SPINE, INC. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767 |
| K222515 | Dio Medical Corporation |
2100 Campus Lane, Suite 100 | East Norriton | PA | 19403 |
| K112097 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K123497 | FACET-LINK, INC. |
1835 MARKET ST. 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K150223 | FACET-LINK, INC. |
101 ROUNDHILL DRIVE, 2ND FLOOR | ROCKAWAY | NJ | 07866 |
| K192744 | Globus Medical Inc. |
2560 General Armistead Ave. | Audubon | PA | 19403 |
| K083442 | GLOBUS MEDICAL, INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K090952 | GLOBUS MEDICAL, INC. |
2560 GENERAL ARMISTEAD AVE. | AUDUBON | PA | 19403 |
| K031657 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K180729 | Huvexel Co., Ltd |
101-105 Megacenter, SKn Technopark, 124, Sagimakgol-ro | Seongnam-si | 13207 | |
| K090767 | INTERVENTIONAL SPINE, INC. |
13700 ALTON PKWY., SUITE 160 | IRVINE | CA | 92618 |
| K082795 | INTERVENTIONAL SPINE, INC. |
13700 ALTON PKWY., SUITE 160 | IRVINE | CA | 92618 |
| K232877 | K&J Consulting Corporation |
2260 Glenview Dr | Lansdale | PA | 19446 |
| K101364 | LANX, INC. |
390 INTERLOCKEN CRESCENT | BROOMFIELD | CO | 80021 |
| K152137 | LDR SPINE USA |
13785 Research Boulevard, Suite 200 | Austin | TX | 78750 |
| K161798 | LDR SPINE USA, INC. |
13785 RESEARCH BLVD | Austin | TX | 78750 |
| K090865 | LIFE SPINE |
2401 W. HASSELL RD. | HOFFMAN ESTATES | IL | 60169 |
| K192281 | Medos International SARL |
Chemin-Blanc 38 | Le Locle | 2400 | |
| K021705 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K013829 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K003928 | MEDTRONIC SOFAMOR DANEK, INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K101765 | MEDTRONIC SPINE LLC. |
1221 CROSSMAN AVE. | SUNNYVALE | CA | 94089 |
| K121551 | NEUROSTRUCTURES, LLC |
4628 NORTHPARK DR | COLORADO SPRINGS | CO | 80918 |
| K131417 | NEXXT SPINE LLC |
8202 SHERMAN ROAD | CHESTERLAND | OH | 44026-2141 |
| K101284 | NUVASIVE, INC. |
7475 LUSK BLVD | SAN DIEGO | CA | 92121 |
| K001323 | NUVASIVE, INC. |
10065 OLD GROVE RD. | SAN DIEGO | CA | 92131 |
| K994308 | NUVASIVE, INC. |
10065 OLD GROVE RD. | SAN DIEGO | CA | 92131 |
| K020411 | NUVASIVE, INC. |
10065 OLD GROVE RD. | SAN DIEGO | CA | 92131 |
| K102438 | OSTEOMED L.P. |
8202 SHERMAN ROAD | CHESTERLAND | OH | 44026 |
| K230297 | Providence Medical Technology, Inc |
4234 Hacienda Drive, Suite 150 | Pleasanton | CA | 94588 |
| K220951 | Providence Medical Technology, Inc |
4234 Hacienda Drive, Suite 150 | Pleasanton | CA | 94588 |
| K230840 | Providence Medical Technology, Inc |
4234 Hacienda Drive, Suite 150 | Pleasanton | CA | 94588 |
| K163374 | PROVIDENCE MEDICAL TECHNOLOGY, INC. |
1331 N. CALIFORNIA BLVD. | WALNUT CREEK | CA | 94596 |
| K251885 | Providence Medical Technology, Inc. |
4234 Hacienda Dr Ste 150 | Pleasanton | CA | 94588 |
| K183589 | Providence Medical Technology, Inc. |
3875 Hopyard Road, | Pleasanton | CA | 94588 |
| K241035 | Providence Medical Technology, Inc. |
4234 Hacienda Dr. | Pleasanton | CA | 94588 |
| K232468 | SC Medica |
3 Quai Kleber - Tour Sebastopol | Strasbourg | 67000 | |
| K132859 | SEASPINE, INC. |
2302 LA MIRADA DR. | VISTA | CA | 92081-7862 |
| K953076 | SOFAMOR DANEK USA,INC. |
1800 PYRAMID PLACE | MEMPHIS | TN | 38132 |
| K132126 | SPECTRUM SPINE, LLC |
100 E. SOUTH MAIN ST. | WAXHAW | NC | 28173 |
| K242527 | Spinal Elements Inc |
3115 S. Melrose Suite 200 | Carlsbad | CA | 92010 |
| K130863 | SPINAL USA |
1835 MARKET STREET, 29TH FLOOR | PHILADELPHIA | PA | 19103 |
| K142980 | SPINE WAVE, INC. |
3 ENTERPRISE DRIVE | SHELTON | CT | 06484 |
| K071420 | SPINEFRONTIER, INC. |
100 CUMMINGS CENTER | BEVERLY | MA | 01915 |
| K092464 | SPINEOLOGY, INC. |
7200 HUDSON BLVD. N. | ST. PAUL | MN | 55128 |
| K240086 | SurGenTec, LLC |
911 Clint Moore Rd | Boca Raton | FL | 33487 |
| K241416 | SurGenTec, LLC |
911 Clint Moore Rd. | Boca Raton | FL | 33487 |
| K243265 | SurGenTec, LLC |
911 Clint More Rd | Boca Raton | FL | 33487 |
| K211855 | SurGenTec, LLC |
911 Clint Moore Rd | Boca Raton | FL | 33487 |
| K073515 | TRANS1 INCORPORATED |
411 LANDMARK DR. | WILMINGTON | NC | 28412 |
| K051856 | TRANS1 INCORPORATED |
1800 SIR TYLER DRIVE | WILMINGTON | NC | 28405 |
| K043351 | TRIAGE MEDICAL INC |
13700 ALTON PKWY. | IRVINE | CA | 92618 |
| K052043 | TRIAGE MEDICAL, INC. |
13700 ALTON PKWY., SUITE 160 | IRVINE | CA | 92618 |
| K051949 | TRIAGE MEDICAL, INC. |
13700 ALTON PKWY., SUITE 160 | IRVINE | CA | 92618 |
| K062391 | TRIAGE MEDICAL, INC. |
13700 ALTON PKWY., SUITE 160 | IRVINE | CA | 92618 |
| K173198 | U&i Corporation |
20, Sandan-ro 76 eon-gil(Rd) | Uijeongbu-si | 11781 | |
| K061041 | US SPINE |
13540 GUILD AVE | APPLE VALLEY | MN | 55124 |
| K123932 | X-SPINE SYSTEMS, INC |
452 Alexandersville Rd | Miamisburg | OH | 45342 |
| K100154 | X-SPINE SYSTEMS, INC. |
452 ALEXANDERSVILLE RD. | MIAMISBURG | OH | 45342 |
| K242650 | ZygoFix Ltd. |
17 T'helet St. | Misgav | 2017400 | |
| K240085 | ZygoFix Ltd. |
17 Tchelet Street | Misgav | 2017900 |
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