Cleared Special

Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor

K250526 · Arthrex, Inc. · Orthopedic
Mar 2025
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K250526 is an FDA 510(k) clearance for the Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Arthrex, Inc. (Naples, US). The FDA issued a Cleared decision on March 14, 2025, 18 days after receiving the submission on February 24, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K250526 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 2025
Decision Date March 14, 2025
Days to Decision 18 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MAI — Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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