FDA 510(k)

WasherCap Mini Fixation System (Model 45)

K-Number: K243712 · 2025-01-30

Decision Date2025-01-30

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

WasherCap Mini Fixation System (Model 45) is a medical device manufactured by Abanza Tecnomed S.L. It received FDA 510(k) clearance on 2025-01-30 under approval 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. It is manufactured by Abanza Tecnomed S.L. The 510(k) number is K243712.

When was WasherCap Mini Fixation System (Model 45) approved by the FDA?

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

What company makes WasherCap Mini Fixation System (Model 45)?

WasherCap Mini Fixation System (Model 45) is manufactured by Abanza Tecnomed S.L.

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.

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Other Devices by Abanza Tecnomed S.L

K212197WasherCap Fixation System K250238WasherCap Fixation System K253618QuadLock Fixation System

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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.