Identity
- Trade Name
- INBONE FDA UDI
- Generic Name
- Ankle prosthesis trial, reusable FDA UDI
- Model / Reference
- 200550003 FDA UDI
Identifiers
- Catalog Number
- 200550003 FDA UDI
- Primary DI / UDI-DI
- 00889797031110 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Ankle prosthesis trial, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3110 FDA UDI
- Commercial Distribution
- 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
No
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
Category: Ankle prosthesis trial, reusable
Introducing the INBONE ankle prosthesis trial device, a reusable and semi-constrained option for orthopedic patients. Designed to provide precise alignment and fit during surgery, this device is made from synthetic polymer or metal material and has been approved by regulatory agencies such as FDA.
Similar devices
Also classified as Ankle prosthesis trial, reusable.
- Hintermann Series — Dt Medtech, LLC · Class I
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- Cadence™ — Ascension Orthopedics, Inc. · Class I
- Cadence™ — Ascension Orthopedics, Inc. · Class I
- XT Revision Ankle Replacement System — Smith & Nephew, Inc. · Class I
- Salto Talaris® — Ascension Orthopedics, Inc. · Class I
- Vantage — Exactech, Inc. · Class I
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 331280c4-3b59-464f-ac7b-75ae8439d82f 35 fields · synced Jul 25, 2026