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FDA 510(k)

Genesys Spine 3DP Cervical Interbody System

K-Number: K191489 · 2020-01-08

ApplicantGenesys Spine
Decision Date2020-01-08
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine 3DP Cervical Interbody System is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2020-01-08 under approval number K191489. 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 Cervical Interbody System?

Genesys Spine 3DP Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2020-01-08. It is manufactured by Genesys Spine. The 510(k) number is K191489.

When was Genesys Spine 3DP Cervical Interbody System approved by the FDA?

Genesys Spine 3DP Cervical Interbody System received FDA 510(k) clearance on 2020-01-08, under approval number K191489.

What company makes Genesys Spine 3DP Cervical Interbody System?

Genesys Spine 3DP Cervical Interbody System is manufactured by Genesys Spine.

What is the FDA product code for Genesys Spine 3DP Cervical Interbody System?

The FDA product code for Genesys Spine 3DP 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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