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510(k) Data Aggregation
K Number
K231944Device Name
CATAMARAN SI Joint Fusion System
Manufacturer
Tenon Medical, Inc.
Date Cleared
2023-08-24
(55 days)
Product Code
OUR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Tenon Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tenon Medical CATAMARAN™ SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Device Description
The CATAMARAN SI Joint Fusion System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis. The CATAMARAN SI Joint Fusion System was developed as a less invasive alternative to traditional open posterior surgical SI Joint fusion. The system consists of the CATAMARAN SI Joint Fixation Implant (Ti6A1-4V ELI Titanium alloy / ASTM F136) included in a reusable System Tray containing: Access, Drill and Delivery, Bone Graft Packing, and Extraction Instruments. The CATAMARAN SI Joint Fixation Implants are designed in various widths and lengths, and allow autologous bone graft material placement in the barrels of the implant to support SI Joint fixation and fusion. The Instrument Set includes Class II single use and reusable surgical instruments designed to facilitate placement of the implant within the sacroillac joint using an inferiorposterior surgical approach. The implants and associated instruments are provided clean and non-sterile and are designed for steam sterilization prior to use.
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K Number
K180818Device Name
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Manufacturer
Tenon Medical, Inc.
Date Cleared
2018-06-13
(76 days)
Product Code
OUR
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Tenon Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tenon Medical Catamaran Sacroiliac Joint Fixation System) is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Device Description
The Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) was developed as a less invasive alternative to traditional open posterior surqical SIJ fusion. The Tenon Medical Catamaran Sacroillac Joint Fixation System (CAT SIJ Fixation System) includes the Catamaran SIJ Implant and associated surgical instruments: an Access Set, a Drill/Delivery and an Accessory Set and an Extraction Set. The titanium implant consists of two hollow barrels connected by a bridge. During the procedure, autologous bone graft material is placed in the barrel of the implant to facilitate stabilization. The Catamaran SIJ Implant is available in two (2) different barrel diameters (7.5mm and 10mm) and two implant lengths (30mm and 40mm) for a total of four sizing options to fit patient anatomy. The Catamaran SIJ Implant is intended for single-use only. The implants and associated components are provided clean and non-sterile and designed for routine steam sterilization prior to use.
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