Identity
- Trade Name
- INBONE FDA UDI
- Generic Name
- Fixed-bearing total ankle prosthesis FDA UDI
- Model / Reference
- 200220904 FDA UDI
Identifiers
- Catalog Number
- 200220904 FDA UDI
- Primary DI / UDI-DI
- 00840420124050 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Fixed-bearing total ankle prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3110 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
MR Conditional FDA UDI
INBONE is a high-quality, FDA-approved fixed-bearing total ankle prosthesis designed to replace damaged or degenerative joints. Featuring a metal and polyethylene articulating component, INBONE offers improved stability, reduced wear and tear, and enhanced mobility for patients undergoing surgery.
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
- Wright Medical Technology, Inc.
Sources (1)
- FDA UDI c1421aa9-e00c-4e22-8709-c6e5a9fc7aeb 36 fields · synced Jul 10, 2026