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510(k) K203507

Vitality® Spinal Fixation System by Zimmer Biomet Spine, Inc. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2021
Date Received
November 30, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to 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)
  • 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)
  • K180227 — Polaris Spinal Growth System (March 15, 2018)

Other clearances for product code NKB

  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K252729 — Universal Spinal System (November 18, 2025)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)