Identity
- Trade Name
- ILIZAROV FDA UDI
- Generic Name
- External orthopaedic fixation system, single-use FDA UDI
- Device Name
- HALF RING 240MM COMPOSITE FDA UDI
- Model / Reference
- 101360 FDA UDI
- Description
- HALF RING 240MM COMPOSITE FDA UDI
Identifiers
- Catalog Number
- 101360 FDA UDI
- Primary DI / UDI-DI
- 03596010030528 FDA UDI
- 510(k) Number
- K994143 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- External orthopaedic fixation system, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- 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
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
MR Conditional FDA UDI
Category: External orthopaedic fixation system, single-use
Ilizarov by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as External orthopaedic fixation system, single-use.
- TRUELOK EVO — Orthofix, Inc. · Class II
- Monkey Rings™ External Fixation System — Paragon 28 · Class II
- OIC External Fixation System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
- TrueLok — Orthofix, Inc. · Class II
- ARBOR — GLOBUS MEDICAL, INC. · Class II
- DRACO — HNM TOTAL RECON LLC · Class II
- PREFIX FIXATOR — Orthofix, Inc. · Class II
- RINGFIX — Stryker Corp. · Class II
Cleared under the same submission
K994143 also covers:
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- ILIZAROV SYSTEMS — MEDICALPLASTIC SRL
- CALANDRUCCIO II — Smith & Nephew, Inc.
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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI c867e18e-2384-411f-8f3d-7a12a4796f0d 36 fields · synced Jun 8, 2026