Cleared Special

Aevumed FASE Suture Anchor

K253040 · Aevumed, Inc. · Orthopedic
Oct 2025
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K253040 is an FDA 510(k) clearance for the Aevumed FASE Suture Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Aevumed, Inc. (Malvern, US). The FDA issued a Cleared decision on October 21, 2025, 29 days after receiving the submission on September 22, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K253040 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2025
Decision Date October 21, 2025
Days to Decision 29 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