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FDA 510(k)

COPELAND MB/HA RESURFACING HUMERAL HEADS

K-Number: K010827 · 2001-09-14

ApplicantBiomet Orthopedics, Inc.
Decision Date2001-09-14
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COPELAND MB/HA RESURFACING HUMERAL HEADS is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Orthopedics, Inc.. It received FDA 510(k) clearance on 2001-09-14 under 510(k) number K010827. 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 MB/HA RESURFACING HUMERAL HEADS?

COPELAND MB/HA RESURFACING HUMERAL HEADS is a medical device that received FDA 510(k) clearance on 2001-09-14. The listed applicant is Biomet Orthopedics, Inc.. The 510(k) number is K010827.

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

COPELAND MB/HA RESURFACING HUMERAL HEADS received FDA 510(k) clearance on 2001-09-14, under 510(k) number K010827.

Who is the listed applicant for COPELAND MB/HA RESURFACING HUMERAL HEADS?

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

What is the FDA product code for COPELAND MB/HA RESURFACING HUMERAL HEADS?

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

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Related Devices (Code: 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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