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 |
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 |
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 |
K163374 |
PROVIDENCE MEDICAL TECHNOLOGY, INC. |
1331 N. CALIFORNIA BLVD.
| WALNUT CREEK |
CA |
94596 |
K183589 |
Providence Medical Technology, Inc. |
3875 Hopyard Road,
| Pleasanton |
CA |
94588 |
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 |
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 |
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 |
|
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