SnugFit All-Suture Anchor extension— 510(k) K230544

Name: FDA 510(k) clearance K230544
Creator: U.S. Food and Drug Administration
Published: 2023-04-17

Substantially Equivalent

Medacta International S.A.

FDA 510(k) clearance K230544 for SnugFit All-Suture Anchor extension, Substantially Equivalent on 2023-04-17. Applicant: Medacta International S.A.. Device class: 2.

Clearance details

Applicant: Medacta International S.A.
Product code: Code MBI
Device class: Class 2
Regulation: 21 CFR 888.3040
Advisory panel: Orthopedic
Date received: 2023-02-28
Decision date: 2023-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Castel San Pietro, CH

Download summary PDF View on FDA.gov ↗

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K262369 — AIR+ All-Inside Meniscal Repair Device, Curved Up; AIR+ All-Inside Meniscal Repair Device, Curved Down2026-07-30

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K253328 — GMK 3D Metal Tibial Tray Extension2026-02-26
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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.