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FDA 510(k)

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

K-Number: K241813 · 2024-08-13

ApplicantSi-Technology, LLC
Decision Date2024-08-13
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Si-Technology, LLC. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241813. 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 SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System?

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Si-Technology, LLC. The 510(k) number is K241813.

When did SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System receive FDA 510(k) clearance?

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241813.

Who is the listed applicant for SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System?

The FDA 510(k) record lists Si-Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System?

The FDA product code for SI-TECHNOLOGY® SI-DESIS® X™ 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_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_RECRUITING

Other records listing Si-Technology, LLC 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.

K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System

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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