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FDA 510(k)

COPELAND RESURFACING HUMERAL HEADS

K-Number: K010664 · 2001-04-05

ApplicantBiomet Manufacturing, Inc.
Decision Date2001-04-05
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COPELAND RESURFACING HUMERAL HEADS 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 2001-04-05 under 510(k) number K010664. The device is classified under product code HSD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COPELAND RESURFACING HUMERAL HEADS?

COPELAND RESURFACING HUMERAL HEADS is a medical device that received FDA 510(k) clearance on 2001-04-05. The listed applicant is Biomet Manufacturing, Inc.. The 510(k) number is K010664.

When did COPELAND RESURFACING HUMERAL HEADS receive FDA 510(k) clearance?

COPELAND RESURFACING HUMERAL HEADS received FDA 510(k) clearance on 2001-04-05, under 510(k) number K010664.

Who is the listed applicant for COPELAND RESURFACING HUMERAL HEADS?

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 COPELAND RESURFACING HUMERAL HEADS?

The FDA product code for COPELAND RESURFACING HUMERAL HEADS is HSD.

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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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