Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K121049
UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM · Globus Medical, Inc. · decided 2012-06-27 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| UNIFY | 597.484 | GLOBUS MEDICAL, INC. | KWQ | 00889095166354 |
| UNIFY | 197.920 | GLOBUS MEDICAL, INC. | KWQ | 00889095190038 |
| UNIFY | 197.244 | GLOBUS MEDICAL, INC. | KWQ | 00889095189155 |
| UNIFY | 197.010 | GLOBUS MEDICAL, INC. | KWQ | 00889095188776 |
| UNIFY | 197.813 | GLOBUS MEDICAL, INC. | KWQ | 00889095189865 |
| UNIFY | 197.713 | GLOBUS MEDICAL, INC. | KWQ | 00889095189797 |
| UNIFY | 597.232 | GLOBUS MEDICAL, INC. | KWQ | 00889095166088 |
| UNIFY | 197.126 | GLOBUS MEDICAL, INC. | KWQ | 00889095189049 |
| UNIFY | 197.484 | GLOBUS MEDICAL, INC. | KWQ | 00889095189360 |
| UNIFY | 597.248 | GLOBUS MEDICAL, INC. | KWQ | 00889095166163 |
| UNIFY | 597.122 | GLOBUS MEDICAL, INC. | KWQ | 00889095166019 |
| UNIFY | 597.238 | GLOBUS MEDICAL, INC. | KWQ | 00889095166118 |
| UNIFY | 197.815 | GLOBUS MEDICAL, INC. | KWQ | 00889095189889 |
| UNIFY | 197.586 | GLOBUS MEDICAL, INC. | KWQ | 00889095189629 |
| UNIFY | 197.468 | GLOBUS MEDICAL, INC. | KWQ | 00889095189322 |
| UNIFY | 197.370 | GLOBUS MEDICAL, INC. | KWQ | 00889095189292 |
| UNIFY | 197.012 | GLOBUS MEDICAL, INC. | KWQ | 00889095188790 |
| UNIFY | 197.349 | GLOBUS MEDICAL, INC. | KWQ | 00889095189223 |
| UNIFY | 597.583 | GLOBUS MEDICAL, INC. | KWQ | 00889095166606 |
| UNIFY | 597.242 | GLOBUS MEDICAL, INC. | KWQ | 00889095166132 |
| UNIFY | 597.480 | GLOBUS MEDICAL, INC. | KWQ | 00889095166347 |
| UNIFY | 597.367 | GLOBUS MEDICAL, INC. | KWQ | 00889095166279 |
| UNIFY | 197.460 | GLOBUS MEDICAL, INC. | KWQ | 00889095189308 |
| UNIFY | 197.046 | GLOBUS MEDICAL, INC. | KWQ | 00889095188950 |
| UNIFY | 197.036 | GLOBUS MEDICAL, INC. | KWQ | 00889095188905 |