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FDA 510(k)

Genesys Spine Sacroiliac Joint Fusion System

K-Number: K191748 · 2019-09-26

ApplicantGenesys Spine
Decision Date2019-09-26
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Genesys Spine Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Genesys Spine. It received FDA 510(k) clearance on 2019-09-26 under 510(k) number K191748. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Genesys Spine Sacroiliac Joint Fusion System?

Genesys Spine Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2019-09-26. The listed applicant is Genesys Spine. The 510(k) number is K191748.

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

Genesys Spine Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2019-09-26, under 510(k) number K191748.

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

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?

The FDA product code for Genesys Spine Sacroiliac Joint Fusion System is OUR.

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 SystemK233595Genesys Spine Sacroiliac Joint Fusion System with NavigationK233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemK220096Genesys Spine 3DP Lumbar Interbody SystemK191489Genesys Spine 3DP Cervical Interbody System

View all 21 devices →

Related Devices (Code: OUR)

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.

K260477CATAMARAN™ SI Joint Fusion SystemTenon MedicalK253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.K253611Falco Fusion SystemMcnicoll Surgical, Inc.K252834Sacroiliac Joint Truss System (SJTS)4Web MedicalK251365OptumSI Implant SystemSi Solutions, LLCK252322SIros-X SystemGenesys Spine

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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