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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
3.5MM LCP PLATE 5 HOLES 72MM FDA UDI
Model / Reference
223.551 FDA UDI
Description
3.5MM LCP PLATE 5 HOLES 72MM FDA UDI

Identifiers

Catalog Number
223551 FDA UDI
Primary DI / UDI-DI
10886982157898 FDA UDI
510(k) Number
K000684 FDA UDI
K082807 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
KTT FDA UDI
GMDN Term
Orthopaedic fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
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

Category: Orthopaedic fixation plate, non-bioabsorbable

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

Similar devices

Also classified as Orthopaedic fixation plate, non-bioabsorbable.

Cleared under the same submission

K000684 also covers:

K082807 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI bfcfd820-b076-4f81-8ea5-dc8c6a7288c8 36 fields · synced May 29, 2026