Cleared Special

K140283 - OSTEOMED EXTREMIFUSE SYSTEM
(FDA 510(k) Clearance)

K140283 · Osteomed · Orthopedic

Feb 2014

Decision

24d

Days

Class 2

Risk

K140283 is an FDA 510(k) clearance for the OSTEOMED EXTREMIFUSE SYSTEM, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on February 28, 2014, 24 days after receiving the submission on February 4, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K140283 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2014
Decision Date	February 28, 2014
Days to Decision	24 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF