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FDA 510(k)

GUIDE WIRES FOR CANNULATED SCREWS

K-Number: K963432 · 1996-11-13

ApplicantOrthopaedic Biosystems, Ltd.
Decision Date1996-11-13
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

GUIDE WIRES FOR CANNULATED SCREWS is the device name listed in this FDA 510(k) record. The listed applicant is Orthopaedic Biosystems, Ltd.. It received FDA 510(k) clearance on 1996-11-13 under 510(k) number K963432. 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 GUIDE WIRES FOR CANNULATED SCREWS?

GUIDE WIRES FOR CANNULATED SCREWS is a medical device that received FDA 510(k) clearance on 1996-11-13. The listed applicant is Orthopaedic Biosystems, Ltd.. The 510(k) number is K963432.

When did GUIDE WIRES FOR CANNULATED SCREWS receive FDA 510(k) clearance?

GUIDE WIRES FOR CANNULATED SCREWS received FDA 510(k) clearance on 1996-11-13, under 510(k) number K963432.

Who is the listed applicant for GUIDE WIRES FOR CANNULATED SCREWS?

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

What is the FDA product code for GUIDE WIRES FOR CANNULATED SCREWS?

The FDA product code for GUIDE WIRES FOR CANNULATED SCREWS is LXT.

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Other records listing Orthopaedic Biosystems, Ltd. 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.

K000797OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01K982996POLYMER OBL SB ANCHOR / SUTURE COMBINATIONK983169POLYMER THREADED ANCHORK982963POLYMER THREADED ANCHOR / SUTURE COMBINATIONK972326PEBA ANCHOR/SUTURE COMBINATIONK963420CANCELLOUS SCREW WASHER

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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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