DEVICE: CD HORIZON Spinal System (00643169576933)

Device Identifier (DI) Information

CD HORIZON Spinal System
6641165
In Commercial Distribution

MEDTRONIC SOFAMOR DANEK, INC.
00643169576933
GS1

1
830350380 *Terms of Use
TAP 6641165 6.5MM CANNULATED
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
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?
32390 Fluted surgical drill bit, reusable
A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OSH Pedicle screw spinal system, adolescent idiopathic scoliosis
NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
HWE INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
MNI ORTHOSIS, SPINAL PEDICLE FIXATION
MNH Orthosis, spondylolisthesis spinal fixation
KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K153463 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 6.5 Millimeter
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Device Record Status

94c4bf9f-ac65-4748-8cbf-d12d58f69f9f
November 22, 2018
4
April 16, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
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