Cleared Traditional

SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D

K121148 · Medical Design, LLC · Orthopedic

Aug 2012

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K121148 is an FDA 510(k) clearance for the SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D, a Screw, Fixation, Bone (Class II — Special Controls, product code HWC), submitted by Medical Design, LLC (Sioux Falls, US). The FDA issued a Cleared decision on August 20, 2012, 126 days after receiving the submission on April 16, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K121148 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 16, 2012
Decision Date	August 20, 2012
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF