DEVICE: CD HORIZON® Spinal System (00643169464735)
Device Identifier (DI) Information
CD HORIZON® Spinal System
7574148
In Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
7574148
In Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
TRAY 7574148 CDHM TRAUMA INST/SCRWS TRAY
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
12143 | Instrument tray, reusable |
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OSH | Pedicle screw spinal system, adolescent idiopathic scoliosis |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
MNH | Orthosis, spondylolisthesis spinal fixation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152248 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 20.981 Inch |
Height: 4.662 Inch |
Width: 10.092 Inch |
Device Record Status
b868ea8c-9e48-4389-88e0-191d2df0a4c8
September 16, 2022
9
June 25, 2016
September 16, 2022
9
June 25, 2016
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 |
---|---|
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