Identity
- Trade Name
- ENDOSKELETON TT FDA UDI
- Generic Name
- Bone lever/elevator, reusable FDA UDI
- Device Name
- DISTRACTOR WEDGE FDA UDI
- Model / Reference
- 4200-1050 FDA UDI
- Description
- DISTRACTOR WEDGE FDA UDI
Identifiers
- Catalog Number
- 4200-1050 FDA UDI
- Primary DI / UDI-DI
- M682420010500 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Bone lever/elevator, reusable 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Endoskeleton Tt 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 60cb7c27-b7f3-4f60-9690-bf982676685f 36 fields · synced May 31, 2026