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510(k) K140276

CD HORIZON SPINAL SYSTEM by Medtronic Sofamor Danek — Product Code OSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2014
Date Received
February 3, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.

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Other clearances for product code OSH

  • K153446 — OLYMPIC Posterior Spinal Fixation System (April 8, 2016)
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  • K132303 — IMPLANET SPINE SYSTEM (October 10, 2013)
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  • K131615 — POLARIS SPINAL SYSTEM (September 4, 2013)
  • K131784 — RANGE SPINAL SYSTEM (August 30, 2013)
  • K131321 — CD HORIZON SPINAL SYSTEM (June 5, 2013)
  • K124058 — CREO STABILIZATION SYSTEM (May 13, 2013)
  • K131030 — RANGE SPINAL SYSTEM (May 9, 2013)