DEVICE: CD Horizon™ Astute™ Spinal System (00763000312947)
Device Identifier (DI) Information
CD Horizon™ Astute™ Spinal System
1608451040
In Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
1608451040
In Commercial Distribution
MEDTRONIC SOFAMOR DANEK, INC.
PEEK ROD 1608451040 6.0 X 6.9MM STR 40MM
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? |
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65116 | Bone-screw internal spinal fixation system rod |
An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KWQ | Appliance, fixation, spinal intervertebral body |
NQP | POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION |
KWP | APPLIANCE, FIXATION, SPINAL INTERLAMINAL |
NKB | Thoracolumbosacral pedicle screw system |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K191066 | 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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Width: 6.9 Millimeter |
Outer Diameter: 40.0 Millimeter |
Length: 6.0 Millimeter |
Device Record Status
5a994c9a-d1f6-41e5-9449-9c91a563ca6d
July 23, 2024
2
August 09, 2020
July 23, 2024
2
August 09, 2020
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