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FDA 510(k)

ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY

K-Number: K874377 · 1988-05-20

ApplicantHarrington Arthritis Research Center
Decision Date1988-05-20
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY is the device name listed in this FDA 510(k) record. The listed applicant is Harrington Arthritis Research Center. It received FDA 510(k) clearance on 1988-05-20 under 510(k) number K874377. 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 ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY?

ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY is a medical device that received FDA 510(k) clearance on 1988-05-20. The listed applicant is Harrington Arthritis Research Center. The 510(k) number is K874377.

When did ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY receive FDA 510(k) clearance?

ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY received FDA 510(k) clearance on 1988-05-20, under 510(k) number K874377.

Who is the listed applicant for ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY?

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

What is the FDA product code for ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY?

The FDA product code for ANATOMIC ADJUSTABLE AXIAL FIXATOR ASSEMBLY 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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