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510(k) Data Aggregation
K Number
K203780Device Name
Harvester SI: Sacroiliac Fixation System
Manufacturer
Date Cleared
2021-03-23
(85 days)
Product Code
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Spinus International, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Harvester SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroillitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
Device Description
The Harvester SI: Sacroiliac Fixation System (also called Harvest SI Sacroiliac Joint Fusion System and Harvester SI Fusion System) is comprised of threaded fusion implants for coupling and fusing the ilium to the sacroiliac fusion). The goal of the fusion arthrodesis is to immobilize the sacroiliac joint with two (2) or more threaded implants. The procedure may or may not be bilateral. The Harvester SI System Fusion implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Harvester SI Fusion System is offered in various diameters and lengths to accommodate patient anatomy. Instruments are provided that facilitate the insertion of the implants.
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