Cleared Traditional

3.Omm Biomet Cannulated Screw System

K143188 · Biomet Manufacturing Corp · Orthopedic
Dec 2014
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K143188 is an FDA 510(k) clearance for the 3.Omm Biomet Cannulated Screw System, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on December 30, 2014, 55 days after receiving the submission on November 5, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K143188 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2014
Decision Date December 30, 2014
Days to Decision 55 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HWC — Screw, Fixation, Bone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040

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