DEVICE: Siconus™ SI Joint Fixation System (B030SCL070350)

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Device Identifier (DI) Information

Siconus™ SI Joint Fixation System
SCL-07-035

CAMBER SPINE TECHNOLOGIES, LLC
B030SCL070350
HIBCC
1
Ø7mm Bone Screw, Cannulated, 35mm
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
OUR Sacroiliac Joint Fixation
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 35 Millimeter
Outer Diameter: 7 Millimeter
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Device Status

In Commercial Distribution
February 03, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-866-643-0739
customerservice@cambermedtech.com
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