DEVICE: DIANA (04047844008423)
Device Identifier (DI) Information
DIANA
IF-Screw
In Commercial Distribution
SJ1918
SIGNUS Medizintechnik GmbH
IF-Screw
In Commercial Distribution
SJ1918
SIGNUS Medizintechnik GmbH
The DIANA Fusion Cage is comprised of a variety of implant sizes to accomodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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58733 | Sacroiliac joint intra-articular arthrodesis implant |
An implantable device designed to achieve and maintain the distraction of degenerated articular surfaces of the sacroiliac joint to assist in intra- and extra-articular bone grafting and fusion (arthrodesis), typically performed to alleviate pain from the sacroiliac joints in skeletally mature patients. The device is a tapered tube made of titanium alloy which has radial fenestrations to encourage bony in-growth. It is surgically implanted under fluoroscopic guidance using an assortment of dedicated tools. It is available in several sizes and intended for permanent implantation.
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FDA Product Code
[?]Product Code | Product Code Name |
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MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K091122 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 0 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 19/18x30mm |
Device Record Status
0d06be1a-203a-4a3c-9b9f-1f872d5f096a
October 11, 2019
5
September 24, 2015
October 11, 2019
5
September 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49602391660
info@signus.com
info@signus.com