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FDA 510(k)

HOWMEDICA THREADED ACETABULAR COMPONENT

K-Number: K850840 · 1985-07-15

ApplicantPfizer, Inc.
Decision Date1985-07-15
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOWMEDICA THREADED ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 1985-07-15 under 510(k) number K850840. 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 HOWMEDICA THREADED ACETABULAR COMPONENT?

HOWMEDICA THREADED ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1985-07-15. The listed applicant is Pfizer, Inc.. The 510(k) number is K850840.

When did HOWMEDICA THREADED ACETABULAR COMPONENT receive FDA 510(k) clearance?

HOWMEDICA THREADED ACETABULAR COMPONENT received FDA 510(k) clearance on 1985-07-15, under 510(k) number K850840.

Who is the listed applicant for HOWMEDICA THREADED ACETABULAR COMPONENT?

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

What is the FDA product code for HOWMEDICA THREADED ACETABULAR COMPONENT?

The FDA product code for HOWMEDICA THREADED ACETABULAR COMPONENT 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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