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FDA 510(k)

TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)

K-Number: K041466 · 2004-07-01

ApplicantBiomet Manufacturing Corp
Decision Date2004-07-01
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) 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 2004-07-01 under 510(k) number K041466. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)?

TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) is a medical device that received FDA 510(k) clearance on 2004-07-01. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K041466.

When did TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) receive FDA 510(k) clearance?

TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) received FDA 510(k) clearance on 2004-07-01, under 510(k) number K041466.

Who is the listed applicant for TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)?

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 TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)?

The FDA product code for TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) is JWH.

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Related Devices (Code: JWH)

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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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