Vendor/Manufacturer: SI-BONE, Inc.
Product/Product Line: iFuse-TORQ™ Implant System
Vendor/Manufacturer Catalog #: 10080T
Global Unique Device (GUD) Primary Device Identifier Number: 00810055520121
Global Unique Device (GUD) Device Description:
10.0mm x 80mm iFuse-TORQ
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Sacroiliac joint transarticular fixation/arthrodesis implant, coated
Global Medical Device Nomenclature (GMDN) Definition:
A sterile implantable device designed to be inserted across the sacroiliac joint to provide temporary stabilization and to encourage long-term joint fusion, typically intended to alleviate pain from the joint. It is made of metal [e.g., titanium (Ti)] with a porous plasma spray coating, typically in the form of a cylinder or rod, possibly with a triangular cross-section. It is typically surgically implanted under fluoroscopic guidance and may include dedicated implantation instruments.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3353
FDA Regulation Description Classification Name:
Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
FDA Classification Product Code(s): OUR
FDA Classification Product Code Device Name(s):
Sacroiliac Joint Fixation
FDA Premarket Submission(s): K203247
The SI-BONE iFuse-TORQ™ Implant System is SUBSTANTIALLY EQUIVALENT to the following product(s):
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