Cleared Traditional

K142823 - Biomet Microfixation Thoracic Fixation System
(FDA 510(k) Clearance)

K142823 · Biomet Microfixation · Orthopedic

Feb 2015

Decision

148d

Days

Class 2

Risk

K142823 is an FDA 510(k) clearance for the Biomet Microfixation Thoracic Fixation System. This device is classified as a Plate, Fixation, Bone (Class II — Special Controls, product code HRS).

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on February 25, 2015, 148 days after receiving the submission on September 30, 2014.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K142823 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2014
Decision Date	February 25, 2015
Days to Decision	148 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF