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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 K191817
Device Name ActivOrtho Continuous Compression Screw System
Applicant
Activortho, Inc.
14405 21st Ave. N
Plymouth,  MN  55447
Applicant Contact Paul Hindrichs
Correspondent
DuVal & Associates, P.A.
825 Nicollet Mall, Suite 1820
Medical Arts Bldg.
Minneapolis,  MN  55402
Correspondent Contact Lisa L. Pritchard
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/05/2019
Decision Date 07/26/2019
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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