Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K192115
SABLE Expandable Spacer · Globus Medical, Inc. · decided 2020-01-14 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| SABLE | 1172.2035S | GLOBUS MEDICAL, INC. | MAX | 00889095965940 |
| SABLE | 1172.2033S | GLOBUS MEDICAL, INC. | MAX | 00889095965926 |
| SABLE | 1172.2021S | GLOBUS MEDICAL, INC. | MAX | 00889095965889 |
| SABLE | 1172.2213S | GLOBUS MEDICAL, INC. | MAX | 00889095966121 |
| SABLE | 1172.2224S | GLOBUS MEDICAL, INC. | MAX | 00889095966169 |
| SABLE | 1172.2210S | GLOBUS MEDICAL, INC. | MAX | 00889095966107 |
| SABLE | 6172.0026 | GLOBUS MEDICAL, INC. | MAX | 00193982003586 |
| SABLE | 6172.0001 | GLOBUS MEDICAL, INC. | MAX | 00193982003524 |
| SABLE | 1172.0013S | GLOBUS MEDICAL, INC. | MAX | 00889095965704 |
| SABLE | 1172.2110S | GLOBUS MEDICAL, INC. | MAX | 00889095966008 |
| SABLE | 6172.0030 | GLOBUS MEDICAL, INC. | MAX | 00193982003593 |
| SABLE | 1172.2121S | GLOBUS MEDICAL, INC. | MAX | 00889095966046 |
| SABLE | 1172.0021S | GLOBUS MEDICAL, INC. | MAX | 00889095965728 |
| SABLE | 1172.0033S | GLOBUS MEDICAL, INC. | MAX | 00889095965766 |
| SABLE | 1172.2024S | GLOBUS MEDICAL, INC. | MAX | 00889095965902 |
| SABLE | 6172.0005 | GLOBUS MEDICAL, INC. | MAX | 00193982003562 |
| SABLE | 6172.0002 | GLOBUS MEDICAL, INC. | MAX | 00193982003531 |
| SABLE | 1172.0035S | GLOBUS MEDICAL, INC. | MAX | 00889095965780 |
| SABLE | 1172.0024S | GLOBUS MEDICAL, INC. | MAX | 00889095965742 |
| SABLE | 1172.2234S | GLOBUS MEDICAL, INC. | MAX | 00889095966183 |
| SABLE | 6172.0022 | GLOBUS MEDICAL, INC. | MAX | 00193982003579 |
| SABLE | 6172.0101 | GLOBUS MEDICAL, INC. | MAX | 00193982003616 |
| SABLE | 1172.2013S | GLOBUS MEDICAL, INC. | MAX | 00889095965865 |
| SABLE | 1172.2133S | GLOBUS MEDICAL, INC. | MAX | 00889095966084 |
| SABLE | 1172.2221S | GLOBUS MEDICAL, INC. | MAX | 00889095966145 |