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510(k) K131983

ITRAC CERVICAL TRACTION SYSTEM by Pivotal Health Solutions — Product Code ITH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 2014
Date Received
June 28, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Equipment, Traction, Powered
Device Class
Class II
Regulation Number
890.5900
Review Panel
PM
Submission Type

Other clearances by Pivotal Health Solutions

  • K101889 — DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE (August 27, 2010)

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  • K103248 — INTEGRITY SPINAL CARE SYSTEM (April 5, 2011)
  • K101889 — DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE (August 27, 2010)