WasherCap Mini Fixation System (Model 45)— 510(k) K243712

Name: FDA 510(k) clearance K243712
Creator: U.S. Food and Drug Administration
Published: 2025-01-30

Substantially Equivalent

Abanza Tecnomed S.L

FDA 510(k) clearance K243712 for WasherCap Mini Fixation System (Model 45), Substantially Equivalent on 2025-01-30. Applicant: Abanza Tecnomed S.L. Device class: 2.

Clearance details

Applicant: Abanza Tecnomed S.L
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2024-12-02
Decision date: 2025-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mutilva, ES

Download summary PDF View on FDA.gov ↗

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More clearances from Abanza Tecnomed S.L

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K253618 — QuadLock Fixation System2026-01-06
K250238 — WasherCap Fixation System2025-02-25
K212197 — WasherCap Fixation System2022-09-22

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.