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FDA 510(k)

PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT

K-Number: K001374 · 2000-07-27

ApplicantBiomet Manufacturing, Inc.
Decision Date2000-07-27
Product CodeKRR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing, Inc.. It received FDA 510(k) clearance on 2000-07-27 under 510(k) number K001374. The device is classified under product code KRR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT?

PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT is a medical device that received FDA 510(k) clearance on 2000-07-27. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K001374.

When did PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT receive FDA 510(k) clearance?

PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT received FDA 510(k) clearance on 2000-07-27, under 510(k) number K001374.

Who is the listed applicant for PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT?

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

What is the FDA product code for PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT?

The FDA product code for PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT is KRR.

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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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