Cleared Special

SnugFit ASA Extension

K251933 · Medacta International S.A. · Orthopedic
Jul 2025
Decision
7d
Days
Class 2
Risk

About This 510(k) Submission

K251933 is an FDA 510(k) clearance for the SnugFit ASA Extension, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on July 1, 2025, 7 days after receiving the submission on June 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K251933 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2025
Decision Date July 01, 2025
Days to Decision 7 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040