Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K191565
Endoskeleton TCS Interbody Fusion Device · Titan Spine, Inc. · decided 2019-08-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ENDOSKELETON® TCS Sterile Barrier System | 5301-3516-S | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00191375027379 |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology | 5386-1606-N | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00763000885984 |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology | 5366-1408-N | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00763000885922 |
| ENDOSKELETON® TCS Sterile Barrier System | 5301-3518-S | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375027393 |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology | 5366-1406-N | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00763000885908 |
| ENDOSKELETON® TCS Sterile Barrier System | 5302-3814-S | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375027591 |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology | 5386-1608-N | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00191375018551 |
| ENDOSKELETON® TCS Sterile Barrier System | 5302-3518-S | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375027553 |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology | 5346-1207-N | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00763000885830 |
| ENDOSKELETON® TCS Sterile Barrier System | 5302-3516-S | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375027539 |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology | 5366-1411-N | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00191375018506 |
| ENDOSKELETON® TCS Sterile Barrier System | 5301-3513-S | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00763000880729 |
| ENDOSKELETON® TCS Sterile Barrier System | 5301-3514-S | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00191375027355 |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology | 5346-1208-N | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00763000885847 |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology | 5366-1410-N | MEDTRONIC SOFAMOR DANEK, INC. | OVD | 00191375018490 |
| ENDOSKELETON® TCS Sterile Barrier System | 5301-3516-S | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00763000880743 |
| ENDOSKELETON® TCS | 5386-1611 | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375011071 |
| ENDOSKELETON® TCS | 5386-1610 | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375011064 |
| ENDOSKELETON® TCS Sterile Barrier System | 5302-3514-S | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375027515 |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology | 5366-1407-N | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00763000885915 |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology | 5346-1209-N | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00763000885854 |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology | 5386-1609-N | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00763000886011 |
| ENDOSKELETON® TCS Sterile Barrier System | 5301-3814-S | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00763000880767 |
| ENDOSKELETON® TCS | 5386-1606 | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375011026 |
| ENDOSKELETON® TCS | 5386-1607 | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375011033 |