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FDA 510(k)

EVOL® ha – Hyper C Cervical Interbody Fusion System

K-Number: K250605 · 2025-03-12

ApplicantCutting Edge Spine, LLC
Decision Date2025-03-12
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EVOL® ha – Hyper C Cervical Interbody Fusion System is a medical device manufactured by Cutting Edge Spine, LLC. It received FDA 510(k) clearance on 2025-03-12 under approval number K250605. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOL® ha – Hyper C Cervical Interbody Fusion System?

EVOL® ha – Hyper C Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-03-12. It is manufactured by Cutting Edge Spine, LLC. The 510(k) number is K250605.

When was EVOL® ha – Hyper C Cervical Interbody Fusion System approved by the FDA?

EVOL® ha – Hyper C Cervical Interbody Fusion System received FDA 510(k) clearance on 2025-03-12, under approval number K250605.

What company makes EVOL® ha – Hyper C Cervical Interbody Fusion System?

EVOL® ha – Hyper C Cervical Interbody Fusion System is manufactured by Cutting Edge Spine, LLC.

What is the FDA product code for EVOL® ha – Hyper C Cervical Interbody Fusion System?

The FDA product code for EVOL® ha – Hyper C Cervical Interbody Fusion System is ODP.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Cutting Edge Spine, LLC

K180674EVOL® ha-C Cervical Interbody Fusion System K180891EVOL Spinal Interbody System, EVOS Lumbar Interbody System K190025EVOL® -SI Joint Fusion System K200991EVOL Spinal Interbody System K200552EVOS Lumbar Interbody System K192497EVOL ha - D Lateral Interbody Fusion System

View all 9 devices →

Related Devices (Code: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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