FDA 510(k)

Mg-PSZ Ceramic Femoral Head

K-Number: K220336 · 2022-09-30

Decision Date2022-09-30

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Mg-PSZ Ceramic Femoral Head is a medical device manufactured by Theken Companies. It received FDA 510(k) clearance on 2022-09-30 under approval number K220336. 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 Mg-PSZ Ceramic Femoral Head?

Mg-PSZ Ceramic Femoral Head is a medical device that received FDA 510(k) clearance on 2022-09-30. It is manufactured by Theken Companies. The 510(k) number is K220336.

When was Mg-PSZ Ceramic Femoral Head approved by the FDA?

Mg-PSZ Ceramic Femoral Head received FDA 510(k) clearance on 2022-09-30, under approval number K220336.

What company makes Mg-PSZ Ceramic Femoral Head?

Mg-PSZ Ceramic Femoral Head is manufactured by Theken Companies.

What is the FDA product code for Mg-PSZ Ceramic Femoral Head?

The FDA product code for Mg-PSZ Ceramic Femoral Head is LPH.

Related Devices (Code: 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.