Identity
- Trade Name
- STAR FDA UDI
- Generic Name
- Coated ankle talus prosthesis FDA UDI
- Device Name
- Talar Component, Single Coated/US Version MEDIUM, LEFT FDA UDI
- Model / Reference
- 400-257 FDA UDI
- Description
- Talar Component, Single Coated/US Version MEDIUM, LEFT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886385016481 FDA UDI
- FDA Product Code
- NTG FDA UDI
- GMDN Term
- Coated ankle talus prosthesis FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 35 Millimeter FDA UDIWidth — 36 Millimeter FDA UDI
Category: Coated ankle talus prosthesis
Star by Stryker Corp. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coated ankle talus prosthesis.
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- Kinos Total Ankle Replacement — Restor3D · Class II
- AGILITY — DEPUY ORTHOPAEDICS, INC. · Class II
- Hintermann Series — Vilex, Inc. · Class II
- Hintermann Series H3 — Dt Medtech, LLC · Class III
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 III | Pending data |
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Manufacturer
- Manufacturer
- Stryker Corp.
Sources (1)
- FDA UDI d5590c2d-4771-4d56-aa0a-108786eedd29 36 fields · synced Jun 1, 2026