Cleared Traditional

K152253 - Biomet Microfixation RibFix Blu Thoracic Fixation System
(FDA 510(k) Clearance)

K152253 · Biomet Microfixation · Orthopedic

Mar 2016

Decision

227d

Days

Class 2

Risk

K152253 is an FDA 510(k) clearance for the Biomet Microfixation RibFix Blu Thoracic Fixation System, a Plate, Fixation, Bone (Class II — Special Controls, product code HRS), submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on March 24, 2016, 227 days after receiving the submission on August 10, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K152253 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 10, 2015
Decision Date	March 24, 2016
Days to Decision	227 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF