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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K191241
Device Name AutoStrut
Applicant
Orthospin
17 Hatechelet St.
Misgav,  IL 2017400
Applicant Contact Oren Cohen
Correspondent
Hogan Lovells U.S. Lpp
1735 Market St., Suite 2300
Hiladelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
OSN  
Date Received05/08/2019
Decision Date 08/14/2019
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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