Cleared Special

K163007 - Biomet Microfixation SternaLock 360 Sternal Closure System
(FDA 510(k) Clearance)

K163007 · Biomet Microfixation · Orthopedic

Nov 2016

Decision

26d

Days

Class 2

Risk

K163007 is an FDA 510(k) clearance for the Biomet Microfixation SternaLock 360 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 November 23, 2016, 26 days after receiving the submission on October 28, 2016.

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

Submission Details

510(k) Number	K163007 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 28, 2016
Decision Date	November 23, 2016
Days to Decision	26 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF