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FDA 510(k)

COPELAND EAS HUMERAL RESURFACING HEADS

K-Number: K051843 · 2005-09-29

ApplicantBiomet, Inc.
Decision Date2005-09-29
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COPELAND EAS HUMERAL RESURFACING HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 2005-09-29 under 510(k) number K051843. 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 EAS HUMERAL RESURFACING HEADS?

COPELAND EAS HUMERAL RESURFACING HEADS is a medical device that received FDA 510(k) clearance on 2005-09-29. The listed applicant is Biomet, Inc.. The 510(k) number is K051843.

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

COPELAND EAS HUMERAL RESURFACING HEADS received FDA 510(k) clearance on 2005-09-29, under 510(k) number K051843.

Who is the listed applicant for COPELAND EAS HUMERAL RESURFACING HEADS?

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 COPELAND EAS HUMERAL RESURFACING HEADS?

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

Related Clinical Trials

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.

Other records listing Biomet, Inc. as applicant

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.

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Related Devices (Code: HSD)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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