FDA 510(k)

AFX Femoral Implant with Inserter

K-Number: K192428 · 2019-10-05

Decision Date2019-10-05

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AFX Femoral Implant with Inserter is a medical device manufactured by Cayenne Medical. It received FDA 510(k) clearance on 2019-10-05 under approval number K192428. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AFX Femoral Implant with Inserter?

AFX Femoral Implant with Inserter is a medical device that received FDA 510(k) clearance on 2019-10-05. It is manufactured by Cayenne Medical. The 510(k) number is K192428.

When was AFX Femoral Implant with Inserter approved by the FDA?

AFX Femoral Implant with Inserter received FDA 510(k) clearance on 2019-10-05, under approval number K192428.

What company makes AFX Femoral Implant with Inserter?

AFX Femoral Implant with Inserter is manufactured by Cayenne Medical.

What is the FDA product code for AFX Femoral Implant with Inserter?

The FDA product code for AFX Femoral Implant with Inserter is MBI.

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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.