Cleared Traditional

K143336 - Biomet Microfixation OmniMax MMF System
(FDA 510(k) Clearance)

K143336 · Biomet Microfixation · Dental

Apr 2015

Decision

132d

Days

Class 2

Risk

K143336 is an FDA 510(k) clearance for the Biomet Microfixation OmniMax MMF System. This device is classified as a Plate, Bone (Class II — Special Controls, product code JEY).

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on April 1, 2015, 132 days after receiving the submission on November 20, 2014.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number	K143336 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2014
Decision Date	April 01, 2015
Days to Decision	132 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF