Cleared Traditional

K130412 - OSTEOMED EXTREMIFUSE SYSTEM
(FDA 510(k) Clearance)

K130412 · Osteomed · Orthopedic

May 2013

Decision

101d

Days

Class 2

Risk

K130412 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 May 31, 2013, 101 days after receiving the submission on February 19, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K130412 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 19, 2013
Decision Date	May 31, 2013
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF