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510(k) K233684

TriALTIS™ Spine System by Medos International SARL — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2023
Date Received
November 16, 2023
Clearance Type
Special
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 Medos International SARL

  • K253249 — TriALTIS™ Spine System (October 21, 2025)
  • K243249 — TriALTIS™ Spine System (January 17, 2025)
  • K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays (September 16, 2024)
  • K242042 — TriALTIS™ Spine System (September 9, 2024)
  • K233366 — SYMPHONY OCT System (November 9, 2023)
  • K232492 — 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor; 2.7 mm GRYPHON™ Flex Knotless Biocomp (October 6, 2023)
  • K231479 — TriALTIS Spine System (September 22, 2023)
  • K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications (February 10, 2023)
  • K223108 — TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear (January 19, 2023)
  • K213978 — TELIGEN System (October 18, 2022)

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)