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FDA 510(k)

SHOULDER FIXATION SYSTEM

K-Number: K060290 · 2006-02-27

ApplicantHand Innovations, LLC
Decision Date2006-02-27
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SHOULDER FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hand Innovations, LLC. It received FDA 510(k) clearance on 2006-02-27 under 510(k) number K060290. 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 SHOULDER FIXATION SYSTEM?

SHOULDER FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2006-02-27. The listed applicant is Hand Innovations, LLC. The 510(k) number is K060290.

When did SHOULDER FIXATION SYSTEM receive FDA 510(k) clearance?

SHOULDER FIXATION SYSTEM received FDA 510(k) clearance on 2006-02-27, under 510(k) number K060290.

Who is the listed applicant for SHOULDER FIXATION SYSTEM?

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

What is the FDA product code for SHOULDER FIXATION SYSTEM?

The FDA product code for SHOULDER FIXATION SYSTEM is LXT.

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Other records listing Hand Innovations, LLC 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.

K061748FRAGMENT PLATE SYSTEMK060864MULTIDIRECTIONAL THREADED PEGK060294DIAPHYSEAL PLATEK052294SHOULDER NAIL PLATEK052248DORSAL NAIL PLATE, ANATOMICALK051728MODIFICATION TO SHOULDER FIXATION 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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