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510(k) K172979

NuVasive® Growth Rod Conversion Set by Nu Vasive, Incorporated — Product Code PGM

K172979 is an FDA 510(k) premarket notification submitted by Nu Vasive, Incorporated for the device "NuVasive® Growth Rod Conversion Set". The FDA issued a decision of Substantially Equivalent on November 6, 2017. The device falls under product code PGM (Growing Rod System), a Class II device regulated under 21 CFR 888.3070. Nu Vasive, Incorporated has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2017
Date Received
September 27, 2017
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 Nu Vasive, Incorporated

  • K231735 — NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interb (July 11, 2023)
  • K230894 — NuVasive Modulus ALIF System (June 16, 2023)
  • K230989 — Rod Registration Frame (May 5, 2023)
  • K223181 — NuVasive Reline System (January 11, 2023)
  • K221751 — NuVasive Cohere ALIF System Intervertebral Body Fusion Device (October 21, 2022)
  • K221388 — NuVasive Reline Cervical System (September 9, 2022)
  • K220478 — NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody (June 21, 2022)
  • K213654 — NuVasive Reline Cervical System (February 23, 2022)
  • K203714 — NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, (December 23, 2021)
  • K212446 — NuVasive Anterior Cervical Plate Systems (November 3, 2021)

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)
  • 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)

FDA data resources