Cleared Special

K121589 - BIOMET MICROFIXATION FACIAL PLATING SYSTEM
(FDA 510(k) Clearance)

K121589 · Biomet Microfixation · Dental

Sep 2012

Decision

113d

Days

Class 2

Risk

K121589 is an FDA 510(k) clearance for the BIOMET MICROFIXATION FACIAL PLATING 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 September 21, 2012, 113 days after receiving the submission on May 31, 2012.

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

Submission Details

510(k) Number	K121589 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2012
Decision Date	September 21, 2012
Days to Decision	113 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF