DEVICE: CD HORIZON® Spinal System (00643169468634)

Device Identifier (DI) Information

CD HORIZON® Spinal System
X1013202
In Commercial Distribution

MEDTRONIC SOFAMOR DANEK, INC.
00643169468634
GS1

1
830350380 *Terms of Use
DRIVER X1013202 CANN RETAINING TWIST
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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?
66243 Bone/joint surgical power tool motorized handpiece/set, electric, reusable
An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a surgical procedure; it is not dedicated to dental procedures. It includes an electric motor and typically one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.
Active false
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FDA Product Code

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

FDA Premarket Submission Number [?] Supplement Number [?]
K143019 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
No Device Sizes
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Device Record Status

ed544388-a728-46a6-be4e-b3f2f1fb98d2
September 19, 2024
6
January 29, 2017
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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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