Identity
- Trade Name
- ILIZAROV FDA UDI
- Generic Name
- Orthopaedic bone cerclage wire FDA UDI
- Device Name
- 1.8MM TITANIUM OLIVE WIRE BAYONET POINT FDA UDI
- Model / Reference
- 71011502 FDA UDI
- Description
- 1.8MM TITANIUM OLIVE WIRE BAYONET POINT FDA UDI
Identifiers
- Catalog Number
- 71011502 FDA UDI
- Primary DI / UDI-DI
- 23596010419419 FDA UDI
- FDA Product Code
- JDW FDA UDI
- GMDN Term
- Orthopaedic bone cerclage wire 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: Orthopaedic bone cerclage wire
Ilizarov by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201253 also covers:
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- HEX-FIX — Smith & Nephew, Inc.
- ILIZAROV — Smith & Nephew, Inc.
- ILIZAROV — Smith & Nephew, Inc.
- ILIZAROV — Smith & Nephew, Inc.
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 71b5e371-9011-44d7-a623-c92fa8cc5823 36 fields · synced Jun 8, 2026