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Lcp

FDA UDI

Class II (US FDA UDI)

by Synthes (u.s.a.) Lp

Identity

Trade Name
LCP FDA UDI
Generic Name
Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Device Name
4.5MM LCP® CONDYLAR PLATE 18 HOLES/386MM-RIGHT FDA UDI
Model / Reference
222.668 FDA UDI
Description
4.5MM LCP® CONDYLAR PLATE 18 HOLES/386MM-RIGHT FDA UDI

Identifiers

Catalog Number
222668 FDA UDI
Primary DI / UDI-DI
10886982157522 FDA UDI
510(k) Number
K000066 FDA UDI
FDA Product Code
HWC FDA UDI
HTY FDA UDI
JDW 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
Not 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

Lcp by Synthes (u.s.a.) Lp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K000066 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes (u.s.a.) Lp

Sources (1)

  • FDA UDI c8518a6a-0513-472a-a748-dbeb106a5b43 37 fields · synced Jun 8, 2026