Identity
- Trade Name
- restor3d Kinos Axiom PSR FDA UDI
- Generic Name
- Osteotomy guide, single-use FDA UDI
- Device Name
- Axiom coupled PSR, Flat-cut FDA UDI
- Model / Reference
- 5831-9006 FDA UDI
- Description
- Axiom coupled PSR, Flat-cut FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097509945 FDA UDI
- 510(k) Number
- K223326 FDA UDI
- FDA Product Code
- OYK FDA UDI
- GMDN Term
- Osteotomy guide, single-use 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Osteotomy guide, single-use
restor3d Kinos Axiom PSR by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Osteotomy guide, single-use.
- Cadence Chamfer Cut Total Ankle System — 3D SYSTEMS, INC. · Class II
- GEO-Desis — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class I
- Salto Talaris Flat Cut Total Ankle System — 3D SYSTEMS, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- Vantage 3D+ PSI — 3D SYSTEMS, INC. · Class II
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Cadence Flat Cut Total Ankle System — 3D SYSTEMS, INC. · Class II
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Restor3D
Sources (1)
- FDA UDI be3c5440-e981-4b6c-bf97-ac07d226408b 34 fields · synced May 30, 2026