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FDA 510(k)

SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE

K-Number: K031428 · 2003-08-08

ApplicantSynthes (Usa)
Decision Date2003-08-08
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2003-08-08 under 510(k) number K031428. 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 SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE?

SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE is a medical device that received FDA 510(k) clearance on 2003-08-08. The listed applicant is Synthes (Usa). The 510(k) number is K031428.

When did SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE receive FDA 510(k) clearance?

SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE received FDA 510(k) clearance on 2003-08-08, under 510(k) number K031428.

Who is the listed applicant for SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE?

The FDA 510(k) record lists Synthes (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE?

The FDA product code for SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE is LXT.

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Other records listing Synthes (Usa) 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.

K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEK120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMK120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMK120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)K111667SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS

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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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