Identity
- Trade Name
- Kinos Axiom Instrumentation FDA UDI
- Generic Name
- Joint prosthesis implantation kit, reusable FDA UDI
- Device Name
- Dual Talar Cut Guide FDA UDI
- Model / Reference
- 5801-1020 FDA UDI
- Description
- Dual Talar Cut Guide FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097508979 FDA UDI
- 510(k) Number
- K192778 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, reusable 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
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Kinos Axiom Instrumentation by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K192778 also covers:
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 ede98261-19b2-45ff-ab2d-7cb5e3cdee6d 35 fields · synced Jun 6, 2026