FDA 510(k)

BioWick X Implant with Driver

K-Number: K172186 · 2017-10-16

Decision Date2017-10-16

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

BioWick X Implant with Driver is a medical device manufactured by Cayenne Medical, Inc.. It received FDA 510(k) clearance on 2017-10-16 under approval number K172186. 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 BioWick X Implant with Driver?

BioWick X Implant with Driver is a medical device that received FDA 510(k) clearance on 2017-10-16. It is manufactured by Cayenne Medical, Inc.. The 510(k) number is K172186.

When was BioWick X Implant with Driver approved by the FDA?

BioWick X Implant with Driver received FDA 510(k) clearance on 2017-10-16, under approval number K172186.

What company makes BioWick X Implant with Driver?

BioWick X Implant with Driver is manufactured by Cayenne Medical, Inc..

What is the FDA product code for BioWick X Implant with Driver?

The FDA product code for BioWick X Implant with Driver is MBI.

Other Devices by Cayenne Medical, Inc.

K161033AFX Femoral Implant With Inserter 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 K161033AFX Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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.