DEVICE: SacroFuse (00190361035947)

Device Identifier (DI) Information

SacroFuse
01-42201-35
In Commercial Distribution

SPINEFRONTIER, INC.
00190361035947
GS1

1
002003243 *Terms of Use
FENESTRATED SCREW, CANNULATED, Ø10MM x 35MM, SACROFUSE
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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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. 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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
OUR Sacroiliac joint fixation
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150017 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 10 Millimeter
Length: 35 Millimeter
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Device Record Status

b555950b-eb75-4344-85e9-4b4453844685
November 28, 2022
4
September 24, 2016
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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
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(866)914-7717
customerservice@spinefrontier.com
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