Cleared Special

JuggerKnot Soft Anchor

K231128 · Riverpoint Medical, LLC · Orthopedic
May 2023
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K231128 is an FDA 510(k) clearance for the JuggerKnot Soft Anchor, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Riverpoint Medical, LLC (Portland, US). The FDA issued a Cleared decision on May 17, 2023, 27 days after receiving the submission on April 20, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231128 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2023
Decision Date May 17, 2023
Days to Decision 27 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