DEVICE: CD HORIZON® Spinal System (00613994610270)

Device Identifier (DI) Information

CD HORIZON® Spinal System
5484859
In Commercial Distribution

MEDTRONIC SOFAMOR DANEK, INC.
00613994610270
GS1

1
830350380 *Terms of Use
SLEEVE 5484859 G5 SEXTANT II INNER
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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?
47831 Orthopaedic implantation sleeve, reusable
A hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. 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
KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
MNH Orthosis, spondylolisthesis spinal fixation
MNI ORTHOSIS, SPINAL PEDICLE FIXATION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K102807 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

4bd9120e-0eb6-4c2b-be08-1dada44fda68
July 06, 2018
3
June 26, 2015
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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

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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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