Cleared Traditional

TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS

K141263 · Biomet Manufacturing Corp · Orthopedic
Nov 2014
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K141263 is an FDA 510(k) clearance for the TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS, a Staple, Fixation, Bone (Class II — Special Controls, product code JDR), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on November 19, 2014, 188 days after receiving the submission on May 15, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number K141263 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2014
Decision Date November 19, 2014
Days to Decision 188 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code JDR — Staple, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3030

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