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510(k) K180674

EVOL® ha-C Cervical Interbody Fusion System by Cutting Edge Spine, LLC — Product Code ODP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2018
Date Received
March 15, 2018
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 Cutting Edge Spine, LLC

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  • K230689 — T-FIX™ 3DSI Joint Fusion System (April 5, 2023)
  • K214123 — T-FIX® 3DSI Joint Fusion System (June 24, 2022)
  • K200991 — EVOL Spinal Interbody System (May 13, 2020)
  • K200552 — EVOS Lumbar Interbody System (April 2, 2020)
  • K192497 — EVOL ha - D Lateral Interbody Fusion System (January 6, 2020)
  • K190025 — EVOL® -SI Joint Fusion System (August 12, 2019)
  • K180891 — EVOL Spinal Interbody System, EVOS Lumbar Interbody System (May 4, 2018)
  • K150321 — EVOS Lumbar Interbody System (July 13, 2015)
  • K102957 — CUTTING EDGE SPINE INTERBODY FUSION DEVICE (April 28, 2011)

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  • 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)
  • K252686 — EffortMed PEEK Cages & Corpectomy Cages (November 21, 2025)