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FDA 510(k)

Genesys Spine Sacroiliac Joint Fusion System with Navigation

K-Number: K233595 · 2024-03-29

ApplicantGenesys Spine
Decision Date2024-03-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Genesys Spine Sacroiliac Joint Fusion System with Navigation is a medical device manufactured by Genesys Spine. It received FDA 510(k) clearance on 2024-03-29 under approval number K233595. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genesys Spine Sacroiliac Joint Fusion System with Navigation?

Genesys Spine Sacroiliac Joint Fusion System with Navigation is a medical device that received FDA 510(k) clearance on 2024-03-29. It is manufactured by Genesys Spine. The 510(k) number is K233595.

When was Genesys Spine Sacroiliac Joint Fusion System with Navigation approved by the FDA?

Genesys Spine Sacroiliac Joint Fusion System with Navigation received FDA 510(k) clearance on 2024-03-29, under approval number K233595.

What company makes Genesys Spine Sacroiliac Joint Fusion System with Navigation?

Genesys Spine Sacroiliac Joint Fusion System with Navigation is manufactured by Genesys Spine.

What is the FDA product code for Genesys Spine Sacroiliac Joint Fusion System with Navigation?

The FDA product code for Genesys Spine Sacroiliac Joint Fusion System with Navigation is OLO.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07173309 Evaluation of Eye Gaze Sharing in the Operating Room RECRUITING NCT07575750 Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) NOT_YET_RECRUITING NCT07174479 Eye Gaze Guidance Evaluation in Phantoms COMPLETED

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: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025)

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: OLO)

K162375Envision 3D: Image Guidance System7D Surgical, Inc. K162341Stryker OrthoMap Precision Knee systemStryker Leibinger GmbH & Co KG K162195TSolution One Cup1 Surgical SystemTHINK Surgical, Inc. K160385Precision ScrewCryptych Pty, Ltd. K153700Aesculap(R) Implant Systems (AIS) S4 Navigation InstrumentsAesculap Implant Systems, LLC K153240Styrker OrthoMap Express Knee SystemStryker Corporate

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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