Identity
- Trade Name
- Endoskeleton TC FDA UDI
- Generic Name
- Metallic spinal interbody fusion cage FDA UDI
- Device Name
- Interbody Fusion Device Parallel Medium 12mm FDA UDI
- Model / Reference
- 5160-1412-S FDA UDI
- Description
- Interbody Fusion Device Parallel Medium 12mm FDA UDI
Identifiers
- Catalog Number
- 5160-1412-S FDA UDI
- Primary DI / UDI-DI
- M68251601412S0 FDA UDI
- FDA Product Code
- ODP 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 — 12 Millimeter FDA UDIDepth — 14 Millimeter FDA UDIWidth — 16 Millimeter FDA UDI
Endoskeleton TC by Titan Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Titan Spine, Inc.
Sources (1)
- FDA UDI 285c69ab-4b62-4b85-91e4-ecc573262273 37 fields · synced Jun 1, 2026