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FDA 510(k)

M2A MAGNUM SYSTEM

K-Number: K042037 · 2004-10-01

ApplicantBiomet, Inc.
Decision Date2004-10-01
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

M2A MAGNUM 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 2004-10-01 under 510(k) number K042037. 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 SYSTEM?

M2A MAGNUM SYSTEM is a medical device that received FDA 510(k) clearance on 2004-10-01. The listed applicant is Biomet, Inc.. The 510(k) number is K042037.

When did M2A MAGNUM SYSTEM receive FDA 510(k) clearance?

M2A MAGNUM SYSTEM received FDA 510(k) clearance on 2004-10-01, under 510(k) number K042037.

Who is the listed applicant for M2A MAGNUM 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 M2A MAGNUM SYSTEM?

The FDA product code for M2A MAGNUM SYSTEM is KWA.

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Other records listing Biomet, Inc. as applicant

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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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