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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 a medical device manufactured by Abanza Tecnomed S.L. It received FDA 510(k) clearance on 2022-09-22 under approval 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. It is manufactured by Abanza Tecnomed S.L. The 510(k) number is K212197.

When was WasherCap Fixation System approved by the FDA?

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

What company makes WasherCap Fixation System?

WasherCap Fixation System is manufactured by Abanza Tecnomed S.L.

What is the FDA product code for WasherCap Fixation System?

The FDA product code for WasherCap Fixation System is MBI.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Other Devices by Abanza Tecnomed S.L

K250238WasherCap™ Fixation System K243712WasherCap™ Mini Fixation System (Model 45) K253618QuadLock™ Fixation System

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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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