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FDA 510(k)

36MM BIOLOX DELTA CERAMIC HEADS

K-Number: K061312 · 2006-06-06

ApplicantBiomet, Inc.
Decision Date2006-06-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

36MM BIOLOX DELTA CERAMIC 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 2006-06-06 under 510(k) number K061312. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 36MM BIOLOX DELTA CERAMIC HEADS?

36MM BIOLOX DELTA CERAMIC HEADS is a medical device that received FDA 510(k) clearance on 2006-06-06. The listed applicant is Biomet, Inc.. The 510(k) number is K061312.

When did 36MM BIOLOX DELTA CERAMIC HEADS receive FDA 510(k) clearance?

36MM BIOLOX DELTA CERAMIC HEADS received FDA 510(k) clearance on 2006-06-06, under 510(k) number K061312.

Who is the listed applicant for 36MM BIOLOX DELTA CERAMIC 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 36MM BIOLOX DELTA CERAMIC HEADS?

The FDA product code for 36MM BIOLOX DELTA CERAMIC HEADS is LZO.

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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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