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FDA 510(k)

ISS OFFSET HEADS

K-Number: K003428 · 2000-11-24

ApplicantBiomet, Inc.
Decision Date2000-11-24
Product CodeHSD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISS OFFSET 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 2000-11-24 under 510(k) number K003428. 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 ISS OFFSET HEADS?

ISS OFFSET HEADS is a medical device that received FDA 510(k) clearance on 2000-11-24. The listed applicant is Biomet, Inc.. The 510(k) number is K003428.

When did ISS OFFSET HEADS receive FDA 510(k) clearance?

ISS OFFSET HEADS received FDA 510(k) clearance on 2000-11-24, under 510(k) number K003428.

Who is the listed applicant for ISS OFFSET 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 ISS OFFSET HEADS?

The FDA product code for ISS OFFSET 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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