Cleared Traditional

JuggerKnot Soft Anchor

K203740 · Riverpoint Medical · Orthopedic
Feb 2021
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K203740 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 (Portland, US). The FDA issued a Cleared decision on February 12, 2021, 52 days after receiving the submission on December 22, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K203740 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 2020
Decision Date February 12, 2021
Days to Decision 52 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