Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K183557
Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device · Titan Spine, Inc. · decided 2019-02-11 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology | 2320-0120-N | MEDTRONIC SOFAMOR DANEK, INC. | OVD | 00191375026198 |
| ENDOSKELETON® TL nanoLOCK® Surface Technology | 7107-1311-N | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00191375016281 |
| ENDOSKELETON® TA nanoLOCK® Surface Technology | 2107-0215-N | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00191375012177 |
| ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology | 2316-0212-N | MEDTRONIC SOFAMOR DANEK, INC. | OVD | 00191375025931 |
| ENDOSKELETON® TL nanoLOCK® Surface Technology | 7107-1510-N | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00191375016250 |
| ENDOSKELETON® TAS nanoLOCK® Surface Technology | 2307-0111-N | MEDTRONIC SOFAMOR DANEK, INC. | OVD | 00191375013761 |
| ENDOSKELETON® TL | 7107-1212 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00191375007005 |
| ENDOSKELETON® TC | 5186-1612 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00191375003786 |
| ENDOSKELETON® TC | 5186-1608 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00191375003748 |
| ENDOSKELETON® TC | 5166-1411 | MEDTRONIC SOFAMOR DANEK, INC. | ODP | 00191375003694 |
| ENDOSKELETON® TCS Sterile Barrier System | 5301-3516-S | MEDTRONIC SOFAMOR DANEK, INC. | OVE | 00191375027379 |
| ENDOSKELETON® TL nanoLOCK® Surface Technology | 7107-1108-N | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00191375016113 |
| ENDOSKELETON® TAS nanoLOCK® Surface Technology | 2307-0117-N | MEDTRONIC SOFAMOR DANEK, INC. | OVD | 00191375013822 |
| 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® TAS Hyperlordotic nanoLOCK® Surface Technology | 2316-0220-N | MEDTRONIC SOFAMOR DANEK, INC. | OVD | 00191375026013 |
| ENDOSKELETON® TAS nanoLOCK® Surface Technology | 2312-0217-N | MEDTRONIC SOFAMOR DANEK, INC. | OVD | 00191375014225 |
| ENDOSKELETON® TCS | 5366-1408 | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375010968 |
| ENDOSKELETON® TL | 7107-1113 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00191375007043 |
| ENDOSKELETON® TO | 3110-3113 | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00191375004578 |
| ENDOSKELETON® TCS Sterile Barrier System | 5301-3518-S | MEDTRONIC SOFAMOR DANEK, INC. | ODP OVE | 00191375027393 |
| ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology | 2316-0116-N | MEDTRONIC SOFAMOR DANEK, INC. | OVD | 00191375025870 |
| ENDOSKELETON® TL nanoLOCK® Surface Technology | 7107-1211-N | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00191375016274 |
| ENDOSKELETON® TL nanoLOCK® Surface Technology | 7107-0110-N | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00191375015765 |
| ENDOSKELETON® TT nanoLOCK® Surface Technology | 4114-3513-N | MEDTRONIC SOFAMOR DANEK, INC. | MAX | 00191375012719 |