DEVICE: CD HORIZON® Spinal System (00613994419804)
Device Identifier (DI) Information
CD HORIZON® Spinal System
X1207030
Not in Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
X1207030
Not in Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
SCREW X1207030 CAN SS MA 6.5X45 4.5 ROD
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? |
---|---|---|---|---|
61325 | Bone-screw internal spinal fixation system, non-sterile |
An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
MNH | Orthosis, spondylolisthesis spinal fixation |
KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K032265 | 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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No Device Sizes |
Device Record Status
44859172-2e0c-475a-b720-0e3a9c5cd7e0
July 02, 2025
5
July 27, 2015
July 02, 2025
5
July 27, 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 |
---|---|---|---|---|---|
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