DEVICE: CD HORIZON® Spinal System (00643169491083)
Device Identifier (DI) Information
CD HORIZON® Spinal System
6640002
In Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
6640002
In Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
INSERTER 6640002 PERC INSERTER
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? |
---|---|---|---|---|
12696 | Orthopaedic inorganic implant inserter/extractor, reusable |
A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MNH | Orthosis, spondylolisthesis spinal fixation |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
OSH | Pedicle screw spinal system, adolescent idiopathic scoliosis |
KWQ | APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
NKB | Orthosis, spinal pedicle fixation, for degenerative disc disease |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152248 | 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
c3c062f0-a299-4a9a-9fe9-cfe4cfb585ab
September 11, 2024
7
July 30, 2016
September 11, 2024
7
July 30, 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 |
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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