Home / 510(k) Clearances / K243461

510(k) K243461

Calibrate Interbody Systems by Alphatec Spine, Inc.

K243461 is an FDA 510(k) premarket notification submitted by Alphatec Spine, Inc. for the device "Calibrate Interbody Systems". The FDA issued a decision of Substantially Equivalent on March 4, 2025. Alphatec Spine, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253216 — IntraOp Alignment System; CONTOUR3D Bending System (June 25, 2026)
  • K253615 — Invictus Bands System (March 25, 2026)
  • 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)

FDA data resources