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FDA 510(k)

M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT

K-Number: K062995 · 2006-10-31

ApplicantBiomet Manufacturing Corp
Decision Date2006-10-31
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2006-10-31 under 510(k) number K062995. 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 M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT?

M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 2006-10-31. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K062995.

When did M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT receive FDA 510(k) clearance?

M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT received FDA 510(k) clearance on 2006-10-31, under 510(k) number K062995.

Who is the listed applicant for M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT?

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

What is the FDA product code for M2A-MAGNUM TRI-SPIKE ACETABULAR COMPONENT?

The FDA product code for M2A-MAGNUM TRI-SPIKE 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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