DEVICE: CD HORIZON® Spinal System (00613994378927)
Device Identifier (DI) Information
CD HORIZON® Spinal System
X0707045
In Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
X0707045
In Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
SPACER X0707045 XL PER BRACE 10DEG 18
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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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? |
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61230 | Metal-polymer composite spinal interbody fusion cage |
A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is typically in the form of a hollow, porous, threaded and/or fenestrated device made of a non-bioabsorbable synthetic polymer with a metallic coating that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be packaged with the cage.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MAX | Intervertebral fusion device with bone graft, lumbar |
MQP | SPINAL VERTEBRAL BODY REPLACEMENT DEVICE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K090353 | 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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Device Size Text, specify: XL |
Device Record Status
a701ab86-9ceb-466b-b63d-21eb59ab339d
July 21, 2025
5
August 20, 2015
July 21, 2025
5
August 20, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com