Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K161379
ELSA Spacers · Globus Medical, Inc. · decided 2016-09-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ELSA | 1122.0050 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095257946 |
| ELSA | 1122.1050 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334425 |
| ELSA | 1122.2045 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334487 |
| ELSA | 1122.0040 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095257922 |
| ELSA | 1122.0060 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095257960 |
| ELSA | 1122.0460 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095258103 |
| ELSA | 1122.0055 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095257953 |
| ELSA | 1122.0465 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095258110 |
| ELSA | 1122.0045 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095257939 |
| ELSA | 1122.0450 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095258080 |
| ELSA | 1122.1040 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334401 |
| ELSA | 1122.2060 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334517 |
| ELSA | 1122.2040 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334470 |
| ELSA | 1122.1065 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334456 |
| ELSA | 1122.0445 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095258073 |
| ELSA | 1122.0440 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095258066 |
| ELSA | 1122.1045 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334418 |
| ELSA | 1122.2065 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334524 |
| ELSA | 1122.1060 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334449 |
| ELSA | 1122.1055 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334432 |
| ELSA | 1122.0065 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095257977 |
| ELSA | 1122.0165 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095258042 |
| ELSA | 1122.2055 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334500 |
| ELSA | 1122.2050 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095334494 |
| ELSA | 1122.0455 | GLOBUS MEDICAL, INC. | MAX OVD | 00889095258097 |