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FDA 510(k)

Genesys Spine 3DP AIS-C II Cervical Interbody System

K-Number: K233594 · 2023-12-13

ApplicantGenesys Spine
Decision Date2023-12-13
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine 3DP AIS-C II Cervical Interbody System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2023-12-13 under approval number K233594. 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 3DP AIS-C II Cervical Interbody System?

Genesys Spine 3DP AIS-C II Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Genesys Spine. The 510(k) number is K233594.

When was Genesys Spine 3DP AIS-C II Cervical Interbody System approved by the FDA?

Genesys Spine 3DP AIS-C II Cervical Interbody System received FDA 510(k) clearance on 2023-12-13, under approval number K233594.

What company makes Genesys Spine 3DP AIS-C II Cervical Interbody System?

Genesys Spine 3DP AIS-C II Cervical Interbody System is manufactured by Genesys Spine.

What is the FDA product code for Genesys Spine 3DP AIS-C II Cervical Interbody System?

The FDA product code for Genesys Spine 3DP AIS-C II Cervical Interbody System is OVE.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes 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 NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

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

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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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