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510(k) K230116

Vital™ Spinal Fixation System by Zimvie Spine (Zimmer Biomet Spine, Inc.) — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2023
Date Received
January 17, 2023
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 Zimvie Spine (Zimmer Biomet Spine, Inc.)

  • K240647 — Virage® Navigation System (April 5, 2024)
  • K240539 — Vital™ Spinal Fixation System (March 15, 2024)
  • K233443 — Vital™ Navigation System (November 16, 2023)

Other clearances for product code NKB

  • K254274 — ARx® SAI Implant System (April 16, 2026)
  • K260786 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (April 3, 2026)
  • 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)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)