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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 the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2024-03-29 under 510(k) 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. The listed applicant is Genesys Spine. The 510(k) number is K233595.

When did Genesys Spine Sacroiliac Joint Fusion System with Navigation receive FDA 510(k) clearance?

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

Who is the listed applicant for Genesys Spine Sacroiliac Joint Fusion System with Navigation?

The FDA 510(k) record lists Genesys Spine as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05367505Titanium Fusion Implant in Combination With Trans-iliac Screws for Insufficiency Fractures of the PelvisACTIVE_NOT_RECRUITINGNCT05438719MOTUS Total Joint Replacement Investigational Device Exemption StudyACTIVE_NOT_RECRUITINGNCT05870488iFuse TORQ for the Treatment of Sacroiliac Joint DysfunctionACTIVE_NOT_RECRUITINGNCT06909292Sacroiliac (SI) Joint Transfixing and Fusion: Meaningful Long Term Outcomes With Nevro1COMPLETEDNCT07565545Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness OutcomesNOT_YET_RECRUITINGNCT07647757Neurolyser XR for the Treatment of SacroiliitisNOT_YET_RECRUITING

Other records listing Genesys Spine as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252322SIros-X SystemK242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemK233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemK220096Genesys Spine 3DP Lumbar Interbody SystemK191489Genesys Spine 3DP Cervical Interbody SystemK182987Genesys Spine 3DP Lumbar Interbody System

View all 21 devices →

Related Devices (Code: OLO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation CentreK261205SPINEART Navigation Instrument SystemSpineart SAK262121Ion-L Navigated InstrumentsSurGenTec, LLCK261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K261113Op.n™ Spine Navigation and Robotic GuidanceEcential RoboticsK261852OTS HipOrtoma AB

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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