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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K121148
Device Name SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D
Applicant
Medical Design, LLC
6709 S. Minnesota Ave. Suite 204
Sioux Falls,  SD  57108 -2593
Applicant Contact KRISTI VONDRA
Correspondent
Medical Design, LLC
6709 S. Minnesota Ave. Suite 204
Sioux Falls,  SD  57108 -2593
Correspondent Contact KRISTI VONDRA
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
OUR  
Date Received04/16/2012
Decision Date 08/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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