Identity
- Trade Name
- Kinos Total Ankle Instrumentation FDA UDI
- Generic Name
- Surgical saw blade, reciprocating, reusable FDA UDI
- Device Name
- Short X-Blade, Right FDA UDI
- Model / Reference
- 5801-4074 FDA UDI
- Description
- Short X-Blade, Right FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840097517742 FDA UDI
- 510(k) Number
- K232595 FDA UDI
- FDA Product Code
- HSN FDA UDI
- GMDN Term
- Surgical saw blade, reciprocating, reusable 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
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
Category: Surgical saw blade, reciprocating, reusable
Kinos Total Ankle Instrumentation by Restor3D — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical saw blade, reciprocating, reusable.
- Long Bullnose Blade 22x0.6mm — Bien-Air Surgery SA · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- Long Bullnose Blade 32x0.6mm — Bien-Air Surgery SA · Class I
- Long Bullnose Blade 27x0.6mm — Bien-Air Surgery SA · Class I
- Short Bullnose Blade 27x0.4mm — Bien-Air Surgery SA · Class I
- AESCULAP — AESCULAP, INC. · Class I
- Short Microsaw Blade 22x0.6mm — Bien-Air Surgery SA · Class I
- KOMET Surgical Saw Blade — Gebr. Brasseler GmbH & Co. KG · Class I
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 18de4938-7ce0-4959-874e-9c64a3fdcde5 34 fields · synced Jun 1, 2026