Identity
- Trade Name
- Kinos Axiom Instrumentation FDA UDI
- Generic Name
- Joint prosthesis implantation kit, single-use FDA UDI
- Device Name
- Right Angle Drill Tip 9mm, Non-Sterile FDA UDI
- Model / Reference
- 5801-3109 FDA UDI
- Description
- Right Angle Drill Tip 9mm, Non-Sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097509006 FDA UDI
- 510(k) Number
- K232595 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Joint prosthesis implantation kit, 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Joint prosthesis implantation kit, single-use
Kinos Axiom Instrumentation by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K232595 also covers:
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
- Kinos Axiom Instrumentation — Restor3D
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 3b0b6dae-fe6c-4c85-8e27-c51c075d0714 34 fields · synced May 30, 2026