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Ilizarov

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name
ILIZAROV FDA UDI
Generic Name
Orthopaedic bone cerclage wire FDA UDI
Device Name
1.8MM TITANIUM WIRE SMOOTH BAYONET POINT FDA UDI
Model / Reference
71111500 FDA UDI
Description
1.8MM TITANIUM WIRE SMOOTH BAYONET POINT FDA UDI

Identifiers

Catalog Number
71111500 FDA UDI
Primary DI / UDI-DI
00885556014691 FDA UDI
510(k) Number
K201253 FDA UDI
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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
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

Similar devices

Also classified as Orthopaedic bone cerclage wire.

Cleared under the same submission

K201253 also covers:

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 c142c012-be90-4716-90e9-a3b4b5aeb175 36 fields · synced Jun 8, 2026