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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 K130627
Device Name SWING-OFF SCREW
Applicant
Advanced Interventional Technology, LLC
7000 Cashell Manor Ct.
Derwood,  MD  20855
Applicant Contact EDUARDO MARCH
Correspondent
Advanced Interventional Technology, LLC
7000 Cashell Manor Ct.
Derwood,  MD  20855
Correspondent Contact EDUARDO MARCH
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/08/2013
Decision Date 08/21/2013
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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