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FDA 510(k)

ATH METAL:UHMWPE TOTAL HIP SYSTEM

K-Number: K882675 · 1988-08-19

ApplicantKinamed, Inc.
Decision Date1988-08-19
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ATH METAL:UHMWPE TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kinamed, Inc.. It received FDA 510(k) clearance on 1988-08-19 under 510(k) number K882675. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ATH METAL:UHMWPE TOTAL HIP SYSTEM?

ATH METAL:UHMWPE TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1988-08-19. The listed applicant is Kinamed, Inc.. The 510(k) number is K882675.

When did ATH METAL:UHMWPE TOTAL HIP SYSTEM receive FDA 510(k) clearance?

ATH METAL:UHMWPE TOTAL HIP SYSTEM received FDA 510(k) clearance on 1988-08-19, under 510(k) number K882675.

Who is the listed applicant for ATH METAL:UHMWPE TOTAL HIP SYSTEM?

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

What is the FDA product code for ATH METAL:UHMWPE TOTAL HIP SYSTEM?

The FDA product code for ATH METAL:UHMWPE TOTAL HIP SYSTEM is KWA.

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Other records listing Kinamed, 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.

K122049NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEMK072250SUPERCABLE GRIP AND PLATE SYSTEMK050897NAVIPRO SHOULDER SOFTWARE MODULEK033668NAVIPRO KNEE SOFTWARE MODULEK032950GEM INSET PATELLAR COMPONENTK030256ISO-ELASTIC CERCLAGE SYSTEM

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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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