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FDA 510(k)

AFX Femoral Implant with Inserter

K-Number: K192428 · 2019-10-05

ApplicantCayenne Medical
Decision Date2019-10-05
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AFX Femoral Implant with Inserter is the device name listed in this FDA 510(k) record. The listed applicant is Cayenne Medical. It received FDA 510(k) clearance on 2019-10-05 under 510(k) 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. The listed applicant is Cayenne Medical. The 510(k) number is K192428.

When did AFX Femoral Implant with Inserter receive FDA 510(k) clearance?

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

Who is the listed applicant for AFX Femoral Implant with Inserter?

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

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

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

Other records listing Cayenne Medical 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.

K180274Ventix Link Knotless Anchor with InserterK172186BioWick X Implant with DriverK161033AFX™ Femoral Implant With Inserter

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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