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510(k) K232586

Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System by K&J Consulting Corp. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2023
Date Received
August 25, 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 K&J Consulting Corp.

  • K250335 — IVA & AEON Cervical and Lumbar Cage System (August 29, 2025)
  • K233332 — Statera-C™ Spinal System (November 27, 2023)
  • K231460 — FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate Syst (July 16, 2023)

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)