Lcp

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: LCP FDA UDI
Generic Name: Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name: LCP VOLAR COLUMN DISTAL RADIUS PL 9H HEAD/3H SHAFT/LT FDA UDI
Model / Reference: 02.110.331 FDA UDI
Description: LCP VOLAR COLUMN DISTAL RADIUS PL 9H HEAD/3H SHAFT/LT FDA UDI

Identifiers

Catalog Number: 02110331 FDA UDI
Primary DI / UDI-DI: 10886982030641 FDA UDI
510(k) Number: K091644 FDA UDI
FDA Product Code: HWC FDA UDI
HRS FDA UDI
GMDN Term: Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic fixation plate, non-bioabsorbable

Lcp by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K091644 also covers:

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: Synthes

Sources (1)

FDA UDI b61301ce-4d4b-4b33-a3be-9a145adcd11f 36 fields · synced May 30, 2026