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Lcp

FDA UDI

Class I (US FDA UDI)

by Synthes

Identity

Trade Name
LCP FDA UDI
Generic Name
Orthopaedic implant-instrument extension adaptor, reusable FDA UDI
Device Name
CLAMPING FOOT FOR 328.040 LCP 2.7/3.5MM MED DISTAL TIBIA LT FDA UDI
Model / Reference
328.311 FDA UDI
Description
CLAMPING FOOT FOR 328.040 LCP 2.7/3.5MM MED DISTAL TIBIA LT FDA UDI

Identifiers

Catalog Number
328311 FDA UDI
Primary DI / UDI-DI
10886982191625 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Orthopaedic implant-instrument extension adaptor, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

Yes

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 implant-instrument extension adaptor, reusable

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

Similar devices

Also classified as Orthopaedic implant-instrument extension adaptor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Synthes

Sources (1)

  • FDA UDI 8486ac73-1d81-408c-9463-e744761635a8 35 fields · synced May 31, 2026