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510(k) K141509

ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS by Medos Sarl — Product Code PGM

K141509 is an FDA 510(k) premarket notification submitted by Medos Sarl for the device "ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS". The FDA issued a decision of Substantially Equivalent on August 22, 2014. The device falls under product code PGM (Growing Rod System), a Class II device regulated under 21 CFR 888.3070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2014
Date Received
June 6, 2014
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 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)
  • K150200 — CD HORIZON Growth Rod Conversion Set (February 25, 2015)

FDA data resources