Cleared Special

CONMED Argo Knotless? Anchor

K251530 · Conmed Corporation · Orthopedic
Jun 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K251530 is an FDA 510(k) clearance for the CONMED Argo Knotless? Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on June 18, 2025, 30 days after receiving the submission on May 19, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K251530 FDA.gov
FDA Decision Cleared SESE
Date Received May 19, 2025
Decision Date June 18, 2025
Days to Decision 30 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