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FDA 510(k)

DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM

K-Number: K050932 · 2005-04-26

ApplicantHand Innovations, Inc.
Decision Date2005-04-26
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hand Innovations, Inc.. It received FDA 510(k) clearance on 2005-04-26 under 510(k) number K050932. 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 VOLAR RADIUS ANATOMICAL PLATE SYSTEM?

DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-26. The listed applicant is Hand Innovations, Inc.. The 510(k) number is K050932.

When did DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM receive FDA 510(k) clearance?

DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM received FDA 510(k) clearance on 2005-04-26, under 510(k) number K050932.

Who is the listed applicant for DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM?

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

What is the FDA product code for DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM?

The FDA product code for DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM is LXT.

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Other records listing Hand Innovations, Inc. as applicant

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.

K042059SHOULDER FIXATION SYSTEMK041157MODIFICATION TO SMALL BONE FIXATION SYSTEMK041081FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRESK033406SMALL BONE FIXATION SYSTEMK032705DISTAL RADIUS FRACTURE REPAIR SYSTEMK030198HAND INNOVATIONS, INC. DISTAL RADIUS FRACTURE REPAIR SYSTEM

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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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