Identity
- Trade Name
- Kinos Axiom FDA UDI
- Generic Name
- Coated ankle tibia prosthesis FDA UDI
- Device Name
- Kinos Axiom Flat Top Talar Implant, Size 2, Right FDA UDI
- Model / Reference
- 2831.0212 FDA UDI
- Description
- Kinos Axiom Flat Top Talar Implant, Size 2, Right FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007995163 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Coated ankle tibia 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
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Moist Heat or Steam Sterilization FDA UDI
Kinos Axiom by Restor3D — 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
- Restor3D
Sources (1)
- FDA UDI 2205f898-4f3e-4c1b-afbe-fd69fe73050e 34 fields · synced May 31, 2026