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FDA 510(k)

SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS

K-Number: K073135 · 2008-01-29

ApplicantSynthes (Usa)
Decision Date2008-01-29
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa). It received FDA 510(k) clearance on 2008-01-29 under 510(k) number K073135. 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) HYBRID EXTERNAL FIXATOR MODIFICATIONS?

SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS is a medical device that received FDA 510(k) clearance on 2008-01-29. The listed applicant is Synthes (Usa). The 510(k) number is K073135.

When did SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS receive FDA 510(k) clearance?

SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS received FDA 510(k) clearance on 2008-01-29, under 510(k) number K073135.

Who is the listed applicant for SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS?

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) HYBRID EXTERNAL FIXATOR MODIFICATIONS?

The FDA product code for SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS 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.K063832SYNTHES (USA) ELBOW HINGE FIXATORSynthes (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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