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FDA 510(k)

PTA (PROGRESSIVE TIBIAL ALIGNMENT)

K-Number: K060403 · 2006-03-28

ApplicantMeridian Medical
Decision Date2006-03-28
Product CodeLXT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PTA (PROGRESSIVE TIBIAL ALIGNMENT) is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Medical. It received FDA 510(k) clearance on 2006-03-28 under 510(k) number K060403. 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 PTA (PROGRESSIVE TIBIAL ALIGNMENT)?

PTA (PROGRESSIVE TIBIAL ALIGNMENT) is a medical device that received FDA 510(k) clearance on 2006-03-28. The listed applicant is Meridian Medical. The 510(k) number is K060403.

When did PTA (PROGRESSIVE TIBIAL ALIGNMENT) receive FDA 510(k) clearance?

PTA (PROGRESSIVE TIBIAL ALIGNMENT) received FDA 510(k) clearance on 2006-03-28, under 510(k) number K060403.

Who is the listed applicant for PTA (PROGRESSIVE TIBIAL ALIGNMENT)?

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

What is the FDA product code for PTA (PROGRESSIVE TIBIAL ALIGNMENT)?

The FDA product code for PTA (PROGRESSIVE TIBIAL ALIGNMENT) is LXT.

Related Clinical Trials

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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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