Cleared Traditional

Acu-Sinch Knotless Mini

K243624 · Acumed, LLC · Orthopedic
Jan 2025
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K243624 is an FDA 510(k) clearance for the Acu-Sinch Knotless Mini, a Washer, Bolt Nut (Class II — Special Controls, product code HTN), submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on January 23, 2025, 59 days after receiving the submission on November 25, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K243624 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2024
Decision Date January 23, 2025
Days to Decision 59 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HTN — Washer, Bolt Nut
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030