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FDA 510(k)

WasherCap™ Fixation System

K-Number: K250238 · 2025-02-25

ApplicantAbanza Tecnomed S.L
Decision Date2025-02-25
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 2025-02-25 under 510(k) number K250238. 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 2025-02-25. The listed applicant is Abanza Tecnomed S.L. The 510(k) number is K250238.

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

WasherCap™ Fixation System received FDA 510(k) clearance on 2025-02-25, under 510(k) number K250238.

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 SystemK243712WasherCap™ Mini Fixation System (Model 45)K212197WasherCap Fixation System

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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