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FDA 510(k)

BIOMET MODULAR FEMORAL REVISION SYSTEM

K-Number: K090757 · 2009-09-25

ApplicantBiomet, Inc.
Decision Date2009-09-25
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BIOMET MODULAR FEMORAL REVISION 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 2009-09-25 under 510(k) number K090757. 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 BIOMET MODULAR FEMORAL REVISION SYSTEM?

BIOMET MODULAR FEMORAL REVISION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-09-25. The listed applicant is Biomet, Inc.. The 510(k) number is K090757.

When did BIOMET MODULAR FEMORAL REVISION SYSTEM receive FDA 510(k) clearance?

BIOMET MODULAR FEMORAL REVISION SYSTEM received FDA 510(k) clearance on 2009-09-25, under 510(k) number K090757.

Who is the listed applicant for BIOMET MODULAR FEMORAL REVISION 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 BIOMET MODULAR FEMORAL REVISION SYSTEM?

The FDA product code for BIOMET MODULAR FEMORAL REVISION 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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