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FDA 510(k)

WasherCap Fixation System

K-Number: K212197 · 2022-09-22

ApplicantAbanza Tecnomed S.L
Decision Date2022-09-22
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WasherCap Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Abanza Tecnomed S.L. It received FDA 510(k) clearance on 2022-09-22 under 510(k) number K212197. 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 WasherCap Fixation System?

WasherCap Fixation System is a medical device that received FDA 510(k) clearance on 2022-09-22. The listed applicant is Abanza Tecnomed S.L. The 510(k) number is K212197.

When did WasherCap Fixation System receive FDA 510(k) clearance?

WasherCap Fixation System received FDA 510(k) clearance on 2022-09-22, under 510(k) number K212197.

Who is the listed applicant for WasherCap Fixation System?

The FDA 510(k) record lists Abanza Tecnomed S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WasherCap Fixation System?

The FDA product code for WasherCap Fixation System is MBI.

Other records listing Abanza Tecnomed S.L 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.

K253618QuadLock™ Fixation SystemK250238WasherCap™ Fixation SystemK243712WasherCap™ Mini Fixation System (Model 45)

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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