Endoskeleton(r) TCS System
510(k) K153122
Endoskeleton(r) TCS System is a Class II device made by Titan Spine, LLC, cleared under FDA 510(k) K153122 on 14 Dec 2015, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153122 | Date14 Dec 2015 | StatusActive |
Official records
- FDA 510(k) database K153122
Recalls
-
- Terminated Z-0086-2022
Engraving on implants may not match what is listed on the pouch labels.
Timeline
- Cleared FDA 510(k) K153122
- Recall initiated FDA recalls Z-0086-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OVE
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K153122
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Endoskeleton TCS 5340-1207-N | 5340-1207-N / 5340-1207-N | M68253401207N0 | Depth 12 mm; Width 14 mm; Height 7 mm | No longer on the market |
| Endoskeleton TCS 5340-1208-N | 5340-1208-N / 5340-1208-N | M68253401208N0 | Height 8 mm; Width 14 mm; Depth 12 mm | No longer on the market |
| Endoskeleton TCS 5340-1210-N | 5340-1210-N / 5340-1210-N | M68253401210N0 | Height 10 mm; Width 14 mm; Depth 12 mm | No longer on the market |
| Endoskeleton TCS 5346-1205-N | 5346-1205-N / 5346-1205-N | M68253461205N0 | Height 5 mm; Width 14 mm; Depth 12 mm; Angle 6 deg | No longer on the market |
| Endoskeleton TCS 5346-1206-N | 5346-1206-N / 5346-1206-N | M68253461206N0 | Height 6 mm; Depth 12 mm; Width 14 mm; Angle 6 deg | No longer on the market |
| Endoskeleton TCS 5346-1208-N | 5346-1208-N / 5346-1208-N | M68253461208N0 | Height 8 mm; Width 14 mm; Depth 12 mm; Angle 6 deg | No longer on the market |
| Endoskeleton TCS 5346-1209-N | 5346-1209-N / 5346-1209-N | M68253461209N0 | Height 9 mm; Depth 12 mm; Width 14 mm; Angle 6 deg | No longer on the market |
| Endoskeleton TCS 5346-1211-N | 5346-1211-N / 5346-1211-N | M68253461211N0 | Height 11 mm; Depth 12 mm; Angle 6 deg; Width 14 mm | No longer on the market |
| Endoskeleton TCS 5360-1405-N | 5360-1405-N / 5360-1405-N | M68253601405N0 | Height 5 mm; Width 16 mm; Depth 14 mm | No longer on the market |
| Endoskeleton TCS 5360-1408-N | 5360-1408-N / 5360-1408-N | M68253601408N0 | Height 8 mm; Width 16 mm; Depth 14 mm | No longer on the market |
| Endoskeleton TCS 5360-1409-N | 5360-1409-N / 5360-1409-N | M68253601409N0 | Height 9 mm; Width 16 mm; Depth 14 mm | No longer on the market |
| Endoskeleton TCS 5360-1412-N | 5360-1412-N / 5360-1412-N | M68253601412N0 | Height 12 mm; Width 16 mm; Depth 14 mm | No longer on the market |
| Endoskeleton TCS 5366-1405-N | 5366-1405-N / 5366-1405-N | M68253661405N0 | Height 5 mm; Depth 14 mm; Angle 6 deg; Width 16 mm | No longer on the market |
| Endoskeleton TCS 5366-1406-N | 5366-1406-N / 5366-1406-N | M68253661406N0 | Height 6 mm; Depth 14 mm; Width 16 mm; Angle 6 deg | No longer on the market |
| Endoskeleton TCS 5366-1407-N | 5366-1407-N / 5366-1407-N | M68253661407N0 | Height 7 mm; Angle 6 deg; Depth 14 mm; Width 16 mm | No longer on the market |
| Endoskeleton TCS 5366-1412-N | 5366-1412-N / 5366-1412-N | M68253661412N0 | Height 12 mm; Width 16 mm; Depth 14 mm; Angle 6 deg | No longer on the market |
| Endoskeleton TCS 5380-1605-N | 5380-1605-N / 5380-1605-N | M68253801605N0 | Height 5 mm; Width 18 mm; Depth 16 mm | No longer on the market |
| Endoskeleton TCS 5380-1606-N | 5380-1606-N / 5380-1606-N | M68253801606N0 | Height 6 mm; Depth 16 mm; Width 18 mm | No longer on the market |
| Endoskeleton TCS 5380-1610-N | 5380-1610-N / 5380-1610-N | M68253801610N0 | Height 10 mm; Width 18 mm; Depth 16 mm | No longer on the market |
| Endoskeleton TCS 5380-1612-N | 5380-1612-N / 5380-1612-N | M68253801612N0 | Height 12 mm; Width 18 mm; Depth 16 mm | No longer on the market |
| Endoskeleton TCS 5386-1605-N | 5386-1605-N / 5386-1605-N | M68253861605N0 | Height 5 mm; Depth 16 mm; Angle 6 deg; Width 18 mm | No longer on the market |
| Endoskeleton TCS 5386-1606-N | 5386-1606-N / 5386-1606-N | M68253861606N0 | Height 6 mm; Width 18 mm; Depth 16 mm; Angle 6 deg | No longer on the market |
| Endoskeleton TCS 5386-1607-N | 5386-1607-N / 5386-1607-N | M68253861607N0 | Height 7 mm; Depth 16 mm; Width 18 mm; Angle 6 deg | No longer on the market |
| Endoskeleton TCS 5386-1608-N | 5386-1608-N / 5386-1608-N | M68253861608N0 | Height 8 mm; Width 18 mm; Depth 16 mm; Angle 6 deg | No longer on the market |
| Endoskeleton TCS 5386-1610-N | 5386-1610-N / 5386-1610-N | M68253861610N0 | Height 10 mm; Angle 6 deg; Width 18 mm; Depth 16 mm | No longer on the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5346-1207-N | 5346-1207-N | 00191375018384 | Angle 6 deg; Depth 12 mm; Width 14 mm; Height 7 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5346-1208-N | 5346-1208-N | 00191375018391 | Depth 12 mm; Angle 6 deg; Width 14 mm; Height 8 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5346-1210-N | 5346-1210-N | 00191375018414 | Width 14 mm; Depth 12 mm; Angle 6 deg; Height 10 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5346-1212-N | 5346-1212-N | 00191375018438 | Angle 6 deg; Depth 12 mm; Width 14 mm; Height 12 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5366-1405-N | 5366-1405-N | 00191375018445 | Width 16 mm; Depth 14 mm; Angle 6 deg; Height 5 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5366-1409-N | 5366-1409-N | 00191375018483 | Angle 6 deg; Depth 14 mm; Width 16 mm; Height 9 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5366-1410-N | 5366-1410-N | 00191375018490 | Width 16 mm; Depth 14 mm; Angle 6 deg; Height 10 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5366-1412-N | 5366-1412-N | 00191375018513 | Width 16 mm; Depth 14 mm; Angle 6 deg; Height 12 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5386-1605-N | 5386-1605-N | 00191375018520 | Depth 16 mm; Angle 6 deg; Width 18 mm; Height 5 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5386-1606-N | 5386-1606-N | 00191375018537 | Depth 16 mm; Width 18 mm; Angle 6 deg; Height 6 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5386-1607-N | 5386-1607-N | 00191375018544 | Depth 16 mm; Angle 6 deg; Width 18 mm; Height 7 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5386-1609-N | 5386-1609-N | 00191375018568 | Width 18 mm; Depth 16 mm; Angle 6 deg; Height 9 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5386-1610-N | 5386-1610-N | 00191375018575 | Angle 6 deg; Depth 16 mm; Width 18 mm; Height 10 mm | On the market |
| ENDOSKELETON® TCS nanoLOCK® Surface Technology 5386-1612-N | 5386-1612-N | 00191375018599 | Width 18 mm; Depth 16 mm; Angle 6 deg; Height 12 mm | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5346-1208-N | 5346-1208-N | 00763000885847 | — | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5346-1209-N | 5346-1209-N | 00763000885854 | — | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5346-1212-N | 5346-1212-N | 00763000885885 | — | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5366-1408-N | 5366-1408-N | 00763000885922 | — | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5366-1409-N | 5366-1409-N | 00763000885939 | — | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5366-1410-N | 5366-1410-N | 00763000885946 | — | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5366-1411-N | 5366-1411-N | 00763000885953 | — | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5386-1605-N | 5386-1605-N | 00763000885977 | — | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5386-1609-N | 5386-1609-N | 00763000886011 | — | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5386-1611-N | 5386-1611-N | 00763000886035 | — | On the market |
| Endoskeleton™ TCS Interbody System with Titan nanoLOCK™ Surface Technology 5386-1612-N | 5386-1612-N | 00763000886042 | — | On the market |
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