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510(k) K172327

VMA™ System version 3.0 by Ortho Kinematics, Inc. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2017
Date Received
August 1, 2017
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)
  • 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)
  • K112109 — THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL (December 22, 2011)

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