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510(k) K140276

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

K140276 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek for the device "CD HORIZON SPINAL SYSTEM". The FDA issued a decision of Substantially Equivalent on March 13, 2014. The device falls under product code OSH (Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis), a Class II device regulated under 21 CFR 888.3070. Medtronic Sofamor Danek has at least 10 other 510(k) clearances on record.

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.

Other clearances by Medtronic Sofamor Danek

  • K251193 — Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone Graft (June 12, 2025)
  • K243706 — Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft Granul (January 17, 2025)
  • K230716 — Robotic Graft Delivery Instruments (July 18, 2023)
  • K212428 — Centerpiece Plate Fixation System (December 13, 2021)
  • K201267 — Adaptix Interbody System with Titan nanoLOCK Surface Technology (August 26, 2020)
  • K173125 — T2 STRATOSPHERE™ Expandable Corpectomy System (December 20, 2017)
  • K172199 — ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESC (September 19, 2017)
  • K171031 — CRESCENT™ Spinal System (July 6, 2017)
  • K171468 — FUSE Spinal System (June 13, 2017)
  • K170679 — CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® (May 11, 2017)

Other clearances for product code OSH

  • K153446 — OLYMPIC Posterior Spinal Fixation System (April 8, 2016)
  • K132574 — PASS LP SPINAL SYSTEM (November 8, 2013)
  • K132303 — IMPLANET SPINE SYSTEM (October 10, 2013)
  • K132575 — PASS LP SPINAL SYSTEM (October 3, 2013)
  • K131802 — EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM (September 12, 2013)
  • 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)

FDA data resources