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FDA 510(k)

DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW

K-Number: K132704 · 2013-10-09

ApplicantBiomet
Decision Date2013-10-09
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW is the device name listed in this FDA 510(k) record. The listed applicant is Biomet. It received FDA 510(k) clearance on 2013-10-09 under 510(k) number K132704. 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 DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW?

DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW is a medical device that received FDA 510(k) clearance on 2013-10-09. The listed applicant is Biomet. The 510(k) number is K132704.

When did DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW receive FDA 510(k) clearance?

DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW received FDA 510(k) clearance on 2013-10-09, under 510(k) number K132704.

Who is the listed applicant for DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW?

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

What is the FDA product code for DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW?

The FDA product code for DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW 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, LLCK112345DISTAL 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)K063832SYNTHES (USA) ELBOW HINGE FIXATORSynthes (Usa)

Official Source

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

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