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FDA 510(k)

HEX-FIX FIELD FIXATOR

K-Number: K953397 · 1995-10-31

ApplicantSmith & Nephew Richards, Inc.
Decision Date1995-10-31
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HEX-FIX FIELD FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Richards, Inc.. It received FDA 510(k) clearance on 1995-10-31 under 510(k) number K953397. 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 HEX-FIX FIELD FIXATOR?

HEX-FIX FIELD FIXATOR is a medical device that received FDA 510(k) clearance on 1995-10-31. The listed applicant is Smith & Nephew Richards, Inc.. The 510(k) number is K953397.

When did HEX-FIX FIELD FIXATOR receive FDA 510(k) clearance?

HEX-FIX FIELD FIXATOR received FDA 510(k) clearance on 1995-10-31, under 510(k) number K953397.

Who is the listed applicant for HEX-FIX FIELD FIXATOR?

The FDA 510(k) record lists Smith & Nephew Richards, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEX-FIX FIELD FIXATOR?

The FDA product code for HEX-FIX FIELD FIXATOR is LXT.

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Other records listing Smith & Nephew Richards, 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.

K965224EMPOWER ANTERIOR DIRECT SCREWSK963509GLOBAL TAPER TAPERED HIP SYSTEM, GT SPECTRONK960444FINN ROD TO ROD CONNECTORK964163TRIMAX NAIL SYSTEMK962557GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENTK963486REVISION HIP 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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