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FDA 510(k)

WasherCap™ Mini Fixation System (Model 45)

K-Number: K243712 · 2025-01-30

ApplicantAbanza Tecnomed S.L
Decision Date2025-01-30
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WasherCap™ Mini Fixation System (Model 45) 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 2025-01-30 under 510(k) number K243712. 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™ Mini Fixation System (Model 45)?

WasherCap™ Mini Fixation System (Model 45) is a medical device that received FDA 510(k) clearance on 2025-01-30. The listed applicant is Abanza Tecnomed S.L. The 510(k) number is K243712.

When did WasherCap™ Mini Fixation System (Model 45) receive FDA 510(k) clearance?

WasherCap™ Mini Fixation System (Model 45) received FDA 510(k) clearance on 2025-01-30, under 510(k) number K243712.

Who is the listed applicant for WasherCap™ Mini Fixation System (Model 45)?

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™ Mini Fixation System (Model 45)?

The FDA product code for WasherCap™ Mini Fixation System (Model 45) 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 SystemK212197WasherCap 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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