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510(k) K112109

THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE by Ortho Kinematics, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2011
Date Received
July 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

Other clearances by Ortho Kinematics, Inc.

  • K173247 — Surgical Planning Software version 1.1 (November 8, 2017)
  • K172327 — VMA™ System version 3.0 (August 25, 2017)
  • K171617 — OKI Surgical Planning Software (August 22, 2017)
  • K133875 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION N (January 17, 2014)
  • K130743 — THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION N (August 6, 2013)

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