Cleared Traditional

JuggerStitch Meniscal Repair Device

K150424 · Biomet Manufacturing Corp · Orthopedic
May 2015
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K150424 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 Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on May 15, 2015, 85 days after receiving the submission on February 19, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K150424 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2015
Decision Date May 15, 2015
Days to Decision 85 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