Home / 510(k) Clearances / K150200

510(k) K150200

CD HORIZON Growth Rod Conversion Set by Medtronic Sofamor Danek USA, Incorporated — Product Code PGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2015
Date Received
January 29, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Growing Rod System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Stabilization or correction of spinal deformities without the use of fusion.

Other clearances by Medtronic Sofamor Danek USA, Incorporated

  • K152604 — KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set (January 6, 2016)

Other clearances for product code PGM

  • K251961 — SDS Growing Rod (January 15, 2026)
  • K241816 — VerteGlide Spinal Growth Guidance System (March 14, 2025)
  • K213196 — MARVEL™ Growing Rods (December 19, 2022)
  • K193224 — Daytona® Small Stature Growth Rod Conversion Set (February 13, 2020)
  • K191212 — CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fen (September 24, 2019)
  • K181068 — CREO® Stabilization System, REVERE® Stabilization System (June 29, 2018)
  • K180227 — Polaris Spinal Growth System (March 15, 2018)
  • K172979 — NuVasive® Growth Rod Conversion Set (November 6, 2017)
  • K161028 — K2M Growing Spine System (July 22, 2016)
  • K142114 — Xia® Growth Rod Conversion Set (October 27, 2014)