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FDA 510(k)

CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)

K-Number: K032169 · 2003-09-22

ApplicantCyberorthology, Inc.
Decision Date2003-09-22
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) is the device name listed in this FDA 510(k) record. The listed applicant is Cyberorthology, Inc.. It received FDA 510(k) clearance on 2003-09-22 under 510(k) number K032169. 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 CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)?

CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) is a medical device that received FDA 510(k) clearance on 2003-09-22. The listed applicant is Cyberorthology, Inc.. The 510(k) number is K032169.

When did CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) receive FDA 510(k) clearance?

CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) received FDA 510(k) clearance on 2003-09-22, under 510(k) number K032169.

Who is the listed applicant for CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)?

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

What is the FDA product code for CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING)?

The FDA product code for CARBON FIBER COMPOSITE CIRCULAR FIXATION (CIRFIX) DEVICE (HALF RING) is LXT.

Related Clinical Trials

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.

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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

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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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