DEVICE: Siconus™ SI Joint Fixation System (B030SCL070600)
Device Identifier (DI) Information
Siconus™ SI Joint Fixation System
SCL-07-060
In Commercial Distribution
CAMBER SPINE TECHNOLOGIES, LLC
SCL-07-060
In Commercial Distribution
CAMBER SPINE TECHNOLOGIES, LLC
Ø7mm Bone Screw, Cannulated, 60mm
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? |
---|---|---|---|---|
62399 | Sacroiliac joint transarticular fixation/arthrodesis implant, uncoated, non-sterile |
A non-sterile 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.
|
Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OUR | Sacroiliac Joint Fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K162121 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 7 Millimeter |
Length: 60 Millimeter |
Device Record Status
c72433ed-2dbc-4188-955d-5f2aaa51839e
February 05, 2020
4
February 03, 2017
February 05, 2020
4
February 03, 2017
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
[?]
1-866-643-0739
customerservice@cambermedtech.com
customerservice@cambermedtech.com