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FDA 510(k)

Zimmer Biomet Ceramic Heads

K-Number: K181171 · 2019-04-02

ApplicantZimmer, Inc.
Decision Date2019-04-02
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Biomet Ceramic Heads is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2019-04-02 under approval number K181171. 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 Zimmer Biomet Ceramic Heads?

Zimmer Biomet Ceramic Heads is a medical device that received FDA 510(k) clearance on 2019-04-02. It is manufactured by Zimmer, Inc.. The 510(k) number is K181171.

When was Zimmer Biomet Ceramic Heads approved by the FDA?

Zimmer Biomet Ceramic Heads received FDA 510(k) clearance on 2019-04-02, under approval number K181171.

What company makes Zimmer Biomet Ceramic Heads?

Zimmer Biomet Ceramic Heads is manufactured by Zimmer, Inc..

What is the FDA product code for Zimmer Biomet Ceramic Heads?

The FDA product code for Zimmer Biomet Ceramic Heads is LZO.

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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.