Identity
- Trade Name
- Endoskeleton TCS FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- Interbody Fusion Device Parallel Medium 11mm FDA UDI
- Model / Reference
- 5360-1411-S FDA UDI
- Description
- Interbody Fusion Device Parallel Medium 11mm FDA UDI
Identifiers
- Catalog Number
- 5360-1411-S FDA UDI
- Primary DI / UDI-DI
- M68253601411S0 FDA UDI
- 510(k) Number
- K142940 FDA UDI
- FDA Product Code
- ODP FDA UDIOVE FDA UDI
- GMDN Term
- Metallic spinal interbody fusion cage FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 11 Millimeter FDA UDIDepth — 14 Millimeter FDA UDIWidth — 16 Millimeter FDA UDI
Endoskeleton TCS by Titan Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K142940 also covers:
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — Titan Spine, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Titan Spine, Inc.
Sources (1)
- FDA UDI 8d7118d4-3de7-4bf1-8f9f-017992a3d0c0 38 fields · synced Jun 8, 2026