DEVICE: iFuse Granite-Closed Head Implant System (00810055522545)
Device Identifier (DI) Information
iFuse Granite-Closed Head Implant System
105080CH
In Commercial Distribution
Si-Bone Inc.
105080CH
In Commercial Distribution
Si-Bone Inc.
10.5mm x 80mm iFuse-Granite Closed Head Implant
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
58808 | Sacroiliac joint transarticular fixation/arthrodesis implant, coated |
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 metal [e.g., titanium (Ti)] with a porous plasma spray coating, and 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 disposable implantation instruments.
|
Active | true |
61325 | Bone-screw internal spinal fixation system, non-sterile |
An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OUR | Sacroiliac Joint Fixation |
NKB | Thoracolumbosacral Pedicle Screw System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 10.5 Millimeter |
Length: 80 Millimeter |
Device Record Status
b0d6c147-acac-4a1b-8c01-87d250c0c0e8
July 27, 2023
1
July 19, 2023
July 27, 2023
1
July 19, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
855-884-3873
info@si-bone.com
info@si-bone.com