Cleared Special

K161896 - Biomet Microfixation Sternal Closure System
(FDA 510(k) Clearance)

K161896 · Biomet Microfixation · Orthopedic

Aug 2016

Decision

22d

Days

Class 2

Risk

K161896 is an FDA 510(k) clearance for the Biomet Microfixation Sternal Closure 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 August 2, 2016, 22 days after receiving the submission on July 11, 2016.

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

Submission Details

510(k) Number	K161896 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 11, 2016
Decision Date	August 02, 2016
Days to Decision	22 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF