TransFasten - LSF (Lateral Sacroiliac Fusion System)

Basic Information

• Brand Name: TransFasten - LSF (Lateral Sacroiliac Fusion System)
• Primary DI: M73910110650
• Version / Model: 10-1-1065
• Company Name: CAPTIVA SPINE, INC.
• Labeler DUNS: 836975784
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-01
• Public Version: 1
• Public Version Date: 2024-03-11
• Public Version Status: New
• Public Device Record Key: 4cc8dfd7-b883-4e6a-bead-f24a154fef2b

Device Description

Sacroiliac Immobilization Device - 9mm (D) x 65mm (L)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OUR	Sacroiliac Joint Fixation	Orthopedic	888.3040	2
HWC	Screw, Fixation, Bone	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58733	Sacroiliac joint intra-articular arthrodesis implant	An implantable device designed to achieve and maintain the distraction of degenerated articular surfaces of the sacroiliac joint to assist in intra- and extra-articular bone grafting and fusion (arthrodesis), typically performed to alleviate pain from the sacroiliac joints in skeletally mature patients. The device is a tapered tube made of titanium alloy which has radial fenestrations to encourage bony in-growth. It is surgically implanted under fluoroscopic guidance using an assortment of dedicated tools. It is available in several sizes and intended for permanent implantation.	Yes	Active
61485	Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated	An implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically to alleviate pain from the joint. It is made of uncoated metal [e.g., titanium (Ti)], and typically in the form of a cylinder which may be threaded and/or fenestrated. It is typically surgically implanted under fluoroscopic guidance and may include dedicated disposable implantation instruments.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M73910110650	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170475	000