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510(k) K180227

Polaris Spinal Growth System by Zimmer Biomet Spine, Inc. — Product Code PGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2018
Date Received
January 26, 2018
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 Zimmer Biomet Spine, Inc.

  • K212023 — Virage Navigation System (August 27, 2021)
  • K203218 — CaP Spheres Pellet Pack (May 4, 2021)
  • K210275 — Polaris Spinal System (April 2, 2021)
  • K203507 — Vitality® Spinal Fixation System (January 28, 2021)
  • K202309 — Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, (October 8, 2020)
  • K191722 — Vital Navigation System (December 2, 2019)
  • K192133 — Zimmer Biomet Universal Navigation System (October 29, 2019)
  • K190556 — Zimmer Biomet Universal Navigation System (October 24, 2019)
  • K183550 — Vitality® Spinal Fixation System (April 8, 2019)
  • K181096 — Avenue P Cage System (January 15, 2019)

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)
  • 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)