Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K123783
ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS · Globus Medical, Inc. · decided 2013-03-14 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ELLIPSE | 782.941 | GLOBUS MEDICAL, INC. | KWP | 00889095852165 |
| ELLIPSE | 782.943 | GLOBUS MEDICAL, INC. | KWP | 00889095852189 |
| CAPITOL | 611.306 | GLOBUS MEDICAL, INC. | LXH | 00889095142457 |
| CAPITOL | 611.303 | GLOBUS MEDICAL, INC. | LXH | 00889095142440 |
| ELLIPSE | 782.805 | GLOBUS MEDICAL, INC. | KWP | 00889095733556 |
| ELLIPSE | 182.946 | GLOBUS MEDICAL, INC. | KWP | 00889095733532 |
| ELLIPSE | 782.940 | GLOBUS MEDICAL, INC. | KWP | 00889095852158 |
| CAPITOL | 611.300 | GLOBUS MEDICAL, INC. | LXH | 00889095142433 |
| ELLIPSE | 782.987 | GLOBUS MEDICAL, INC. | KWP | 00889095733563 |
| ELLIPSE | 782.944 | GLOBUS MEDICAL, INC. | KWP | 00889095852196 |
| ELLIPSE | 182.941 | GLOBUS MEDICAL, INC. | KWP | 00889095733488 |
| ELLIPSE | 782.945 | GLOBUS MEDICAL, INC. | KWP | 00889095852202 |
| ELLIPSE | 182.940 | GLOBUS MEDICAL, INC. | KWP | 00889095733471 |
| ELLIPSE | 182.943 | GLOBUS MEDICAL, INC. | KWP | 00889095733501 |
| ELLIPSE | 182.987 | GLOBUS MEDICAL, INC. | KWP | 00889095733549 |
| ELLIPSE | 782.942 | GLOBUS MEDICAL, INC. | KWP | 00889095852172 |
| ELLIPSE | 182.945 | GLOBUS MEDICAL, INC. | KWP | 00889095733525 |
| CAPITOL | 611.310 | GLOBUS MEDICAL, INC. | LXH | 00889095142464 |
| ELLIPSE | 182.944 | GLOBUS MEDICAL, INC. | KWP | 00889095733518 |
| ELLIPSE | 782.946 | GLOBUS MEDICAL, INC. | KWP | 00889095852219 |
| ELLIPSE | 182.942 | GLOBUS MEDICAL, INC. | KWP | 00889095733495 |
| ELLIPSE | 182.805 | GLOBUS MEDICAL, INC. | KWP | 00889095733464 |