Cleared Traditional

JuggerKnot Soft Anchor OC

K232411 · Riverpoint Medical, LLC · Orthopedic
Oct 2023
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K232411 is an FDA 510(k) clearance for the JuggerKnot Soft Anchor OC, 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 October 6, 2023, 57 days after receiving the submission on August 10, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K232411 FDA.gov
FDA Decision Cleared SESE
Date Received August 10, 2023
Decision Date October 06, 2023
Days to Decision 57 days
Submission Type Traditional
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