Cleared Special

K151173 - Biomet Microfixation RibFix Blu Thoracic Fixation System
(FDA 510(k) Clearance)

K151173 · Biomet Microfixation · Orthopedic

May 2015

Decision

25d

Days

Class 2

Risk

K151173 is an FDA 510(k) clearance for the Biomet Microfixation RibFix Blu Thoracic Fixation System. This device is classified as a Screw, Fixation, Bone (Class II — Special Controls, product code HWC).

Submitted by Biomet Microfixation (Jacksonville, US). The FDA issued a Cleared decision on May 26, 2015, 25 days after receiving the submission on May 1, 2015.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K151173 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2015
Decision Date	May 26, 2015
Days to Decision	25 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF