Home / 510(k) Clearances / K241816

510(k) K241816

VerteGlide Spinal Growth Guidance System by OrthoPediatrics Corp. — Product Code PGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2025
Date Received
June 24, 2024
Clearance Type
Traditional
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 OrthoPediatrics Corp.

  • K252600 — Pediatric Plating Platform I Small-Mini (October 9, 2025)
  • K251362 — PediFlex™ Flexible Nail System (June 24, 2025)
  • K243963 — Pediatric Plating Platform Hip (April 29, 2025)
  • K250623 — Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur (April 1, 2025)
  • K243798 — Orthex External Fixation System (March 7, 2025)
  • K233105 — RESPONSE™ Rib and Pelvic System (January 20, 2024)
  • K231266 — Pediatric Nailing Platform Tibia (August 21, 2023)
  • K222105 — RESPONSE 5.5/6.0 Cannulated Screw System (March 23, 2023)
  • K223786 — Orthex External Fixation System (February 10, 2023)
  • K220679 — Pediatric Nailing Platform Femur (July 20, 2022)

Other clearances for product code PGM

  • K251961 — SDS Growing Rod (January 15, 2026)
  • 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)
  • K150200 — CD HORIZON Growth Rod Conversion Set (February 25, 2015)
  • K142114 — Xia® Growth Rod Conversion Set (October 27, 2014)