Cleared Special

K121302 - BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
(FDA 510(k) Clearance)

K121302 · Biomet Microfixation · Orthopedic

Sep 2012

Decision

141d

Days

Class 2

Risk

K121302 is an FDA 510(k) clearance for the BIOMET MICROFIXATION STERNAL CLOSURE 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 September 19, 2012, 141 days after receiving the submission on May 1, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K121302 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 01, 2012
Decision Date	September 19, 2012
Days to Decision	141 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF