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510(k) K253331

PressON Spinal Fixation System by Nexus Spine — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2025
Date Received
September 30, 2025
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 Nexus Spine

  • K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
  • K241467 — Stable-C Interbody System (July 17, 2024)
  • K233375 — Tranquil-L Interbody System (March 20, 2024)
  • K240416 — Tranquil-C Interbody System (March 12, 2024)
  • K233234 — PressON Spinal Fixation System (October 26, 2023)
  • K231486 — Stable-L Standalone Lumbar Interbody System (October 12, 2023)
  • K232530 — Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (September 18, 2023)
  • K231763 — Stable-C Interbody System (August 21, 2023)
  • K223529 — PressON Spinal Fixation System (May 2, 2023)
  • K223627 — PreView-III™ Anterior Cervical Plate System (February 2, 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)