Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K143578
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer · Globus Medical, Inc. · decided 2016-04-13 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SIGNATURE | 368.233CS | GLOBUS MEDICAL, INC. | MAX | 00889095276770 |
| TRANSCONTINENTAL | 375.275CS | GLOBUS MEDICAL, INC. | MAX | 00889095242799 |
| COLONIAL | 365.068CS | GLOBUS MEDICAL, INC. | ODP | 00889095236941 |
| TRANSCONTINENTAL | 375.071CS | GLOBUS MEDICAL, INC. | MAX | 00889095240351 |
| TRANSCONTINENTAL | 375.057CS | GLOBUS MEDICAL, INC. | MAX | 00889095240177 |
| SUSTAIN | 304.972CS | GLOBUS MEDICAL, INC. | MAX MQP | 00889095235869 |
| SUSTAIN | 304.869CS | GLOBUS MEDICAL, INC. | MAX MQP | 00889095235609 |
| SIGNATURE | 368.229CS | GLOBUS MEDICAL, INC. | MAX | 00889095276732 |
| TRANSCONTINENTAL | 375.267CS | GLOBUS MEDICAL, INC. | MAX | 00889095242713 |
| COLONIAL | 365.512CS | GLOBUS MEDICAL, INC. | ODP | 00889095237986 |
| COLONIAL | 365.212CS | GLOBUS MEDICAL, INC. | ODP | 00889095237504 |
| COLONIAL | 365.051CS | GLOBUS MEDICAL, INC. | ODP | 00889095236842 |
| SUSTAIN | 304.969CS | GLOBUS MEDICAL, INC. | MAX MQP | 00889095235807 |
| SUSTAIN | 504.231CS | GLOBUS MEDICAL, INC. | MAX | 00889095156430 |
| TRANSCONTINENTAL | 375.717CS | GLOBUS MEDICAL, INC. | MAX | 00889095248654 |
| COLONIAL | 365.511CS | GLOBUS MEDICAL, INC. | ODP | 00889095237962 |
| COLONIAL | 365.009CS | GLOBUS MEDICAL, INC. | ODP | 00889095236644 |
| SUSTAIN | 304.968CS | GLOBUS MEDICAL, INC. | MAX MQP | 00889095235784 |
| SUSTAIN | 304.082CS | GLOBUS MEDICAL, INC. | MAX MQP | 00889095235067 |
| SUSTAIN | 504.109C | GLOBUS MEDICAL, INC. | MAX | 00889095155044 |
| SUSTAIN | 504.108C | GLOBUS MEDICAL, INC. | MAX | 00889095155013 |
| TRANSCONTINENTAL | 375.649CS | GLOBUS MEDICAL, INC. | MAX | 00889095247510 |
| TRANSCONTINENTAL | 375.445CS | GLOBUS MEDICAL, INC. | MAX | 00889095244809 |
| TRANSCONTINENTAL | 375.067CS | GLOBUS MEDICAL, INC. | MAX | 00889095240313 |
| COLONIAL | 365.505CS | GLOBUS MEDICAL, INC. | ODP | 00889095237849 |