Cleared Traditional

K212608 - RibFix Blu Thoracic Fixation System
(FDA 510(k) Clearance)

K212608 · Biomet Microfixation · Orthopedic

Apr 2022

Decision

248d

Days

Class 2

Risk

K212608 is an FDA 510(k) clearance for the 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 April 22, 2022, 248 days after receiving the submission on August 17, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K212608 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 17, 2021
Decision Date	April 22, 2022
Days to Decision	248 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF