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FDA 510(k)

DISTAL RADIUS FRACTURE REPAIR SYSTEM

K-Number: K032705 · 2003-10-01

ApplicantHand Innovations, Inc.
Decision Date2003-10-01
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISTAL RADIUS FRACTURE REPAIR 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 2003-10-01 under 510(k) number K032705. 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 FRACTURE REPAIR SYSTEM?

DISTAL RADIUS FRACTURE REPAIR SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-01. The listed applicant is Hand Innovations, Inc.. The 510(k) number is K032705.

When did DISTAL RADIUS FRACTURE REPAIR SYSTEM receive FDA 510(k) clearance?

DISTAL RADIUS FRACTURE REPAIR SYSTEM received FDA 510(k) clearance on 2003-10-01, under 510(k) number K032705.

Who is the listed applicant for DISTAL RADIUS FRACTURE REPAIR 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 RADIUS FRACTURE REPAIR SYSTEM?

The FDA product code for DISTAL RADIUS FRACTURE REPAIR 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.

K050932DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEMK042059SHOULDER FIXATION SYSTEMK041157MODIFICATION TO SMALL BONE FIXATION SYSTEMK041081FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRESK033406SMALL BONE FIXATION 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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