SI-Cure Sacroiliac Joint Fusion System
K-Number: K223819 · 2023-01-18
ApplicantAlevio, LLC
Decision Date2023-01-18
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SI-Cure Sacroiliac Joint Fusion System is a medical device manufactured by Alevio, LLC. It received FDA 510(k) clearance on 2023-01-18 under approval number K223819. 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-Cure Sacroiliac Joint Fusion System?
SI-Cure Sacroiliac Joint Fusion System is a medical device that received FDA 510(k) clearance on 2023-01-18. It is manufactured by Alevio, LLC. The 510(k) number is K223819.
When was SI-Cure Sacroiliac Joint Fusion System approved by the FDA?
SI-Cure Sacroiliac Joint Fusion System received FDA 510(k) clearance on 2023-01-18, under approval number K223819.
What company makes SI-Cure Sacroiliac Joint Fusion System?
SI-Cure Sacroiliac Joint Fusion System is manufactured by Alevio, LLC.
What is the FDA product code for SI-Cure Sacroiliac Joint Fusion System?
The FDA product code for SI-Cure Sacroiliac Joint Fusion System is OUR.
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Related PubMed Literature
PMID: 41839575
A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement.
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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.