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Ilizarov Systems

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
ILIZAROV SYSTEMS FDA UDI
Generic Name
Orthopaedic bone cerclage wire FDA UDI
Device Name
DRILL TIP WIRE CORTICAL 1.8MM DIAMETER 355 MM FDA UDI
Model / Reference
71933244 FDA UDI
Description
DRILL TIP WIRE CORTICAL 1.8MM DIAMETER 355 MM FDA UDI

Identifiers

Catalog Number
71933244 FDA UDI
Primary DI / UDI-DI
00885556060667 FDA UDI
510(k) Number
K994143 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Orthopaedic bone cerclage wire

Ilizarov Systems by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone cerclage wire.

Cleared under the same submission

K994143 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew, Inc.

Sources (1)

  • FDA UDI d21a812d-c63f-47ce-a4a7-d2ee64909ac8 36 fields · synced Jun 8, 2026