Cleared Traditional

JuggerKnot Soft Anchors

K150768 · Biomet Manufacturing Corp · Orthopedic
Sep 2015
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K150768 is an FDA 510(k) clearance for the JuggerKnot Soft Anchors, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on September 4, 2015, 164 days after receiving the submission on March 24, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K150768 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 2015
Decision Date September 04, 2015
Days to Decision 164 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