Home / 510(k) Clearances / K243461

510(k) K243461

Calibrate Interbody Systems by Alphatec Spine, Inc.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2025
Date Received
November 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • 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)
  • K240951 — Invictus Robotic Navigation Instruments (June 6, 2024)