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 a medical device manufactured by Si-Technology, LLC. It received FDA 510(k) clearance on 2024-08-13 under approval 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. It is manufactured by Si-Technology, LLC. The 510(k) number is K241813.
When was SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System approved by the FDA?
SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2024-08-13, under approval number K241813.
What company makes SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System?
SI-TECHNOLOGY® SI-DESIS® X Sacroiliac Joint Fusion System is manufactured by Si-Technology, LLC.
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
NCT07222787
Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes
RECRUITING
NCT07430293
Hybrid Closed-Loop Insulin Delivery After Pancreatectomy
RECRUITING
NCT06690658
Self-Practicing Upper Body Exercises With a Robotic Trainer System
RECRUITING
NCT05438719
MOTUS Total Joint Replacement Investigational Device Exemption Study
ACTIVE_NOT_RECRUITING
NCT06335082
A Registry Based Collaborative to Measure Efficiency, Effectiveness, and Safety of Farapulse PFA Technology for AF
ENROLLING_BY_INVITATION
NCT07409545
Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes
NOT_YET_RECRUITING
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: 39150225
Lessons on the use of real-world data in medical device research: findings from the National Evaluation System for Health Technology Test-Cases.
Journal of comparative effectiveness research (2024)
PMID: 37365092
Comparison of the international regulations for medical devices-USA versus Europe.
Injury (2023)
PMID: 37288633
[Roadmap of Medical Device for Implanted Brain-computer Interface].
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023)
Other Devices by Si-Technology, LLC
Related Devices (Code: OUR)
K161755Integrity-SI TM Fusion SystemCoorstek Medical
K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd.
K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek
K160652iFUSE Implant SystemSI-BONE, Inc.
K152681iFuse Implant System(R)SI-BONE, Inc.
K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC
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.