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FDA 510(k)

BIOMET EXTERNAL WRIST PLATE

K-Number: K003240 · 2000-12-29

ApplicantBiomet, Inc.
Decision Date2000-12-29
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET EXTERNAL WRIST PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2000-12-29 under 510(k) number K003240. The device is classified under product code LXT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMET EXTERNAL WRIST PLATE?

BIOMET EXTERNAL WRIST PLATE is a medical device that received FDA 510(k) clearance on 2000-12-29. The listed applicant is Biomet, Inc.. The 510(k) number is K003240.

When did BIOMET EXTERNAL WRIST PLATE receive FDA 510(k) clearance?

BIOMET EXTERNAL WRIST PLATE received FDA 510(k) clearance on 2000-12-29, under 510(k) number K003240.

Who is the listed applicant for BIOMET EXTERNAL WRIST PLATE?

The FDA 510(k) record lists Biomet, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOMET EXTERNAL WRIST PLATE?

The FDA product code for BIOMET EXTERNAL WRIST PLATE is LXT.

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Related Devices (Code: LXT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K230067Para-Fix External Fixation SystemNew Paradigm BiomedicalK131636POLARUS CONNECTAcumed, LLCK132704DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROWBiometK112345DISTAL VOLAR RADIUS PLATING SYSTEMSMedos International SARLK090374STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(SDePuy Orthopaedics, Inc.K073135SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONSSynthes (Usa)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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