DEVICE: SacroFuse (00190361036081)
Device Identifier (DI) Information
SacroFuse
01-42300-60
In Commercial Distribution
SPINEFRONTIER, INC.
01-42300-60
In Commercial Distribution
SPINEFRONTIER, INC.
SCREW, SOLID WALL, CANNULATED, Ø8MM X 60MM, SACROFUSE
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OUR | Sacroiliac joint fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K150017 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 60 Millimeter |
Outer Diameter: 8 Millimeter |
Device Record Status
19a53692-3773-4c9b-9100-6b7111046bd6
November 28, 2022
4
September 24, 2016
November 28, 2022
4
September 24, 2016
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 |
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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
[?]
+1(866)914-7717
customerservice@spinefrontier.com
customerservice@spinefrontier.com