Cleared Special

OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor

K243203 · Riverpoint Medical · Orthopedic
Oct 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K243203 is an FDA 510(k) clearance for the OC JuggerKnotless Soft Anchor; OC JuggerLoop Soft Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on October 29, 2024, 28 days after receiving the submission on October 1, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K243203 FDA.gov
FDA Decision Cleared SESE
Date Received October 01, 2024
Decision Date October 29, 2024
Days to Decision 28 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