Identity
- Trade Name
- ENDOSKELETON® TCS Sterile Barrier System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Bone Screw, Standard, 3.5mm x 20mm FDA UDI
- Model / Reference
- 5301-3520-S FDA UDI
- Description
- Bone Screw, Standard, 3.5mm x 20mm FDA UDI
Identifiers
- Catalog Number
- 5301-3520-S FDA UDI
- Primary DI / UDI-DI
- 00191375027416 FDA UDI
- FDA Product Code
- ODP FDA UDIOVE FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable 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
- Length — 20 Millimeter FDA UDIOuter Diameter — 3.5 Millimeter FDA UDI
ENDOSKELETON® TCS Sterile Barrier System by Titan Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K151596 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 — MEDTRONIC SOFAMOR DANEK, INC.
K173535 also covers:
- ENDOSKELETON® TAS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, 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 |
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Manufacturer
- Manufacturer
- Titan Spine, Inc.
Sources (1)
- FDA UDI 8e86250a-867c-4fcd-a91b-441ba77c2042 38 fields · synced Jun 8, 2026