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FDA 510(k)

METAL ON METAL ACETABULAR SYSTEM

K-Number: K993438 · 2000-05-18

ApplicantBiomet, Inc.
Decision Date2000-05-18
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAL ON METAL ACETABULAR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2000-05-18 under 510(k) number K993438. 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 ON METAL ACETABULAR SYSTEM?

METAL ON METAL ACETABULAR SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-18. The listed applicant is Biomet, Inc.. The 510(k) number is K993438.

When did METAL ON METAL ACETABULAR SYSTEM receive FDA 510(k) clearance?

METAL ON METAL ACETABULAR SYSTEM received FDA 510(k) clearance on 2000-05-18, under 510(k) number K993438.

Who is the listed applicant for METAL ON METAL ACETABULAR SYSTEM?

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

What is the FDA product code for METAL ON METAL ACETABULAR SYSTEM?

The FDA product code for METAL ON METAL ACETABULAR SYSTEM is KWA.

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Other records listing Biomet, 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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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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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