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FDA 510(k)

Genesys Spine AIS-C II Cervical Interbody Fusion System

K-Number: K242483 · 2025-02-07

ApplicantGenesys Spine
Decision Date2025-02-07
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine AIS-C II Cervical Interbody Fusion System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2025-02-07 under approval number K242483. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genesys Spine AIS-C II Cervical Interbody Fusion System?

Genesys Spine AIS-C II Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2025-02-07. It is manufactured by Genesys Spine. The 510(k) number is K242483.

When was Genesys Spine AIS-C II Cervical Interbody Fusion System approved by the FDA?

Genesys Spine AIS-C II Cervical Interbody Fusion System received FDA 510(k) clearance on 2025-02-07, under approval number K242483.

What company makes Genesys Spine AIS-C II Cervical Interbody Fusion System?

Genesys Spine AIS-C II Cervical Interbody Fusion System is manufactured by Genesys Spine.

What is the FDA product code for Genesys Spine AIS-C II Cervical Interbody Fusion System?

The FDA product code for Genesys Spine AIS-C II Cervical Interbody Fusion System is OVE.

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 NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_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

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

Other Devices by Genesys Spine

K161438Genesys Spine Apache® Anterior Lumbar Interbody Fusion System K161914Genesys Spine TiLock Cortical Spinal System K152099Genesys Spine Apache® Anchored Cervical Interbody Fusion System K161404Genesys Spine Apache® Lateral Lumbar Interbody Fusion System K153123Genesys Spine Apache Interbody Fusion System K172469TiLock Modular Spinal System

View all 21 devices →

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

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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