Cleared Traditional

JuggerStitch Meniscal Repair Device

K191459 · Biomet, Inc. · Orthopedic
Sep 2019
Decision
102d
Days
Class 2
Risk

About This 510(k) Submission

K191459 is an FDA 510(k) clearance for the JuggerStitch Meniscal Repair Device, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 13, 2019, 102 days after receiving the submission on June 3, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K191459 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2019
Decision Date September 13, 2019
Days to Decision 102 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