Cleared Special

K113512 - BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES SYSTEM
(FDA 510(k) Clearance)

K113512 · Biomet Microfixation · Dental

Jun 2012

Decision

214d

Days

Class 2

Risk

K113512 is an FDA 510(k) clearance for the BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES AND PREBENT PLATES 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 June 29, 2012, 214 days after receiving the submission on November 28, 2011.

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

Submission Details

510(k) Number	K113512 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 28, 2011
Decision Date	June 29, 2012
Days to Decision	214 days
Submission Type	Special
Review Panel	Dental (DE)
Summary	Summary PDF