EVOL® ha Hyper C Cervical Interbody Fusion System— 510(k) K250605

Name: FDA 510(k) clearance K250605
Creator: U.S. Food and Drug Administration
Published: 2025-03-12

Substantially Equivalent

Cutting Edge Spine, LLC

FDA 510(k) clearance K250605 for EVOL® ha Hyper C Cervical Interbody Fusion System, Substantially Equivalent on 2025-03-12. Applicant: Cutting Edge Spine, LLC. Device class: 2.

Clearance details

Applicant: Cutting Edge Spine, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2025-02-28
Decision date: 2025-03-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Mineral Springs, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code ODP

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K262595 — VariLift-C Cervical Interbody Fusion System2026-08-26
K262489 — BluEX Cervical Expandable Cage System2026-08-18
K253041 — 3d Cage Cervical2026-07-23
K262061 — Tritanium® C Anterior Cervical Cage +16 more2026-07-17
K254130 — C.A. Medical Interbody Fusion System2026-07-08

More clearances from Cutting Edge Spine, LLC

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K230689 — T-FIX 3DSI Joint Fusion System2023-04-05
K214123 — T-FIX® 3DSI Joint Fusion System2022-06-24
K200991 — EVOL Spinal Interbody System2020-05-13
K200552 — EVOS Lumbar Interbody System2020-04-02
K192497 — EVOL ha - D Lateral Interbody Fusion System2020-01-06

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.