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FDA 510(k)

Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head

K-Number: K183457 · 2019-11-05

ApplicantZimmer, Inc.
Decision Date2019-11-05
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2019-11-05 under approval number K183457. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head?

Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head is a medical device that received FDA 510(k) clearance on 2019-11-05. It is manufactured by Zimmer, Inc.. The 510(k) number is K183457.

When was Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head approved by the FDA?

Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head received FDA 510(k) clearance on 2019-11-05, under approval number K183457.

What company makes Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head?

Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head is manufactured by Zimmer, Inc..

What is the FDA product code for Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head?

The FDA product code for Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head is LPH.

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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.