FDA 510(k)

AFX Femoral Implant With Inserter

K-Number: K161033 · 2016-08-03

Decision Date2016-08-03

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

AFX Femoral Implant With Inserter is a medical device manufactured by Cayenne Medical, Inc.. It received FDA 510(k) clearance on 2016-08-03 under approval number K161033. 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 2016-08-03. It is manufactured by Cayenne Medical, Inc.. The 510(k) number is K161033.

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

AFX Femoral Implant With Inserter received FDA 510(k) clearance on 2016-08-03, under approval number K161033.

What company makes AFX Femoral Implant With Inserter?

AFX Femoral Implant With Inserter is manufactured by Cayenne Medical, Inc..

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

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

Related Clinical Trials

NCT06368700 The HYALEX Pivotal Study RECRUITING

Other Devices by Cayenne Medical, Inc.

K172186BioWick X Implant with Driver K180274Ventix Link Knotless Anchor with Inserter

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL K160655OrthoButton CLRiverpoint Medical

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.