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510(k) K252205

Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System by Curiteva, Inc. — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 2026
Date Received
July 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Device Class
Class II
Regulation Number
888.3080
Review Panel
OR
Submission Type

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.

Other clearances by Curiteva, Inc.

  • K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System (January 15, 2026)
  • K250845 — Curiteva Porous PEEK Standalone ALIF System (June 18, 2025)
  • K243137 — Curiteva Porous PEEK Laminoplasty System (October 28, 2024)
  • K233360 — Curiteva Thoracolumbar Plate System (February 29, 2024)
  • K233744 — Curiteva Porous PEEK Lumbar Interbody Fusion System (January 18, 2024)
  • K231232 — Curiteva Laminoplasty System (June 28, 2023)
  • K213030 — Curiteva Porous PEEK Cervical Interbody Fusion System (February 13, 2023)
  • K223200 — Curiteva Navigation System (January 6, 2023)
  • K210402 — Curiteva Sacroiliac Joint Fusion System (September 9, 2021)
  • K191810 — Curiteva Pedicle Screw System (August 28, 2019)

Other clearances for product code ODP

  • K254105 — Hive™ Standalone Cervical System and Hive™ C Interbody System (February 13, 2026)
  • K254061 — Curiteva Porous PEEK Cervical Interbody Fusion System (January 15, 2026)
  • K252219 — Cervical Interbody and VBR Fusion System (January 14, 2026)
  • K252711 — Advantage-C™ Ti3D Cervical Interbody Fusion Device (January 8, 2026)
  • K252894 — aprevo® cervical interbody system (January 6, 2026)
  • K252781 — MSFX MIKRON PEEK CAGES (December 19, 2025)
  • K250764 — SpineLinc Anterior Cervical Implant System (December 5, 2025)
  • K250769 — Dakota LP System (November 24, 2025)
  • K250560 — BEE HA (November 21, 2025)
  • K252686 — EffortMed PEEK Cages & Corpectomy Cages (November 21, 2025)