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510(k) K232275

Invictus® Spinal Fixation System by Alphatec Spine, Inc. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2023
Date Received
July 31, 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 Alphatec Spine, Inc.

  • K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For U (February 19, 2026)
  • K252842 — SafeOp 3: Neural Informatix System (January 11, 2026)
  • K251575 — IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interb (September 3, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251080 — IdentiTi II Cervical Interbody System (July 3, 2025)
  • K243461 — Calibrate Interbody Systems (March 4, 2025)
  • K241375 — IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi (February 3, 2025)
  • K242364 — IdentiTi™ II Interbody System (October 4, 2024)
  • K242147 — Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System (September 20, 2024)
  • K241519 — Invictus® Small Stature Spinal Fixation System (June 21, 2024)

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)