Cleared Traditional

K151019 - SternaLock? 360 Sternal Closure System
(FDA 510(k) Clearance)

K151019 · Biomet Microfixation · Orthopedic

Nov 2015

Decision

201d

Days

Class 2

Risk

K151019 is an FDA 510(k) clearance for the 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 3, 2015, 201 days after receiving the submission on April 16, 2015.

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

Submission Details

510(k) Number	K151019 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2015
Decision Date	November 03, 2015
Days to Decision	201 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF