Lcp

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: LCP FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/2.0MM FDA UDI
Model / Reference: 03.111.900 FDA UDI
Description: DRILL TEMPLATE F/2.7MM LCP ULNA OSTEOTOMY PL F/2.0MM FDA UDI

Identifiers

Catalog Number: 03111900 FDA UDI
Primary DI / UDI-DI: 10886982072580 FDA UDI
510(k) Number: K113364 FDA UDI
FDA Product Code: HWC FDA UDI
HRS FDA UDI
GMDN Term: Surgical drill guide, reusable 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

FDA UDI

Implantable

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: Surgical drill guide, reusable

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

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Also classified as Surgical drill guide, reusable.

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Truliant — Exactech, Inc. · Class II
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Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · Class I

Cleared under the same submission

K113364 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 e8434a61-ea0b-4763-b9d4-a935140c57a1 36 fields · synced May 30, 2026