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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K171617
Device Name OKI Surgical Planning Software
Applicant
Ortho Kinematics, Inc.
110 Wild Basin Rd., Suite 250
Austin,  TX  78704
Applicant Contact Adam Deitz
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/01/2017
Decision Date 08/22/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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