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FDA 510(k)

METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)

K-Number: K021349 · 2002-07-01

ApplicantWrightmedicaltechnologyinc
Decision Date2002-07-01
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2002-07-01 under 510(k) number K021349. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)?

METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) is a medical device that received FDA 510(k) clearance on 2002-07-01. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K021349.

When did METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) receive FDA 510(k) clearance?

METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) received FDA 510(k) clearance on 2002-07-01, under 510(k) number K021349.

Who is the listed applicant for METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)?

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

What is the FDA product code for METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES)?

The FDA product code for METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) is KWA.

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Related Devices (Code: KWA)

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.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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