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FDA 510(k)

BioWick X Implant with Driver

K-Number: K172186 · 2017-10-16

ApplicantCayenne Medical, Inc.
Decision Date2017-10-16
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BioWick X Implant with Driver is the device name listed in this FDA 510(k) record. The listed applicant is Cayenne Medical, Inc.. It received FDA 510(k) clearance on 2017-10-16 under 510(k) 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. The listed applicant is Cayenne Medical, Inc.. The 510(k) number is K172186.

When did BioWick X Implant with Driver receive FDA 510(k) clearance?

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

Who is the listed applicant for BioWick X Implant with Driver?

The FDA 510(k) record lists Cayenne Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Cayenne Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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.

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