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510(k) K211981

KHEIRON® Spinal Fixation System by S.M.A.I.O — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2022
Date Received
June 25, 2021
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 S.M.A.I.O

  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)
  • K251804 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 8, 2025)
  • K232650 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (September 29, 2023)
  • K223841 — KBA3D (May 30, 2023)
  • K213975 — KEOPS Balance Analyzer 3D (May 6, 2022)
  • K211414 — KHEIRON Spinal Fixation System (August 10, 2021)
  • K201659 — KHEIRON® Spinal Fixation System (October 5, 2020)

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)