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510(k) K250605

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

K250605 is an FDA 510(k) premarket notification submitted by Cutting Edge Spine, LLC for the device "EVOL® ha – Hyper C Cervical Interbody Fusion System". The FDA issued a decision of Substantially Equivalent on March 12, 2025. The device falls under product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical), a Class II device regulated under 21 CFR 888.3080. Cutting Edge Spine, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2025
Date Received
February 28, 2025
Clearance Type
Special
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

  • 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)
  • K180674 — EVOL® ha-C Cervical Interbody Fusion System (June 25, 2018)
  • 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)

Other clearances for product code ODP

  • K260840 — BluEX Cervical Expandable Cage System (May 16, 2026)
  • K260850 — OSTEOMNI SPINAL CAGES SYSTEM (May 12, 2026)
  • K260549 — ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System (April 24, 2026)
  • K253260 — ORIO-3D Cage System (April 16, 2026)
  • K260340 — HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, (April 13, 2026)
  • K242303 — MOD-C (April 1, 2026)
  • K252240 — Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System (March 30, 2026)
  • K252432 — Flex-Z™ Cervical Cage (March 25, 2026)
  • K254105 — Hive™ Standalone Cervical System and Hive™ C Interbody System (February 13, 2026)
  • K252205 — Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Inte (January 16, 2026)

FDA data resources