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FDA 510(k)

A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM

K-Number: K042458 · 2004-10-07

ApplicantA.M. Surgical, Inc.
Decision Date2004-10-07
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is A.M. Surgical, Inc.. It received FDA 510(k) clearance on 2004-10-07 under 510(k) number K042458. 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 A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM?

A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is A.M. Surgical, Inc.. The 510(k) number is K042458.

When did A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM receive FDA 510(k) clearance?

A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042458.

Who is the listed applicant for A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM?

The FDA 510(k) record lists A.M. Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM?

The FDA product code for A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM is LXT.

Related Clinical Trials

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Other records listing A.M. Surgical, 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.

K191771SECURE ScrewK191345Pegasus SystemK180087A.M. Surgical Intramedullary Fixation DeviceK080133MOUNTABLE ENDOSCOPIC BLADEK982142MOUNTABLE ENDOSCOPIC KNIFE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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