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510(k) K130249

INTEGRITY SPINAL CARE SYSTEM 3.0 by Integrity Life Sciences — Product Code ITH

K130249 is an FDA 510(k) premarket notification submitted by Integrity Life Sciences for the device "INTEGRITY SPINAL CARE SYSTEM 3.0". The FDA issued a decision of Substantially Equivalent on February 6, 2014. The device falls under product code ITH (Equipment, Traction, Powered), a Class II device regulated under 21 CFR 890.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2014
Date Received
February 1, 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

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  • K214037 — Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac (February 22, 2024)
  • K222912 — c1Trac (May 16, 2023)
  • K151640 — ELTRAC 471 (October 16, 2015)
  • K150695 — Modpod (August 13, 2015)
  • K131983 — ITRAC CERVICAL TRACTION SYSTEM (September 10, 2014)
  • K112074 — EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 (February 1, 2012)
  • K103248 — INTEGRITY SPINAL CARE SYSTEM (April 5, 2011)
  • K101889 — DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE (August 27, 2010)

FDA data resources