AccessGUDID - DEVICE: CD HORIZON® Spinal System (00643169465824)

GUDID

Device Identifier (DI) Information

Brand Name: CD HORIZON® Spinal System
Version or Model: X1013185
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169465824
Issuing Agency: GS1
Commercial Distribution End Date: January 14, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: TAP X1013185 9.0MM SOLID

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44491	Multi-purpose surgical power tool system, line-powered	An assembly of devices designed to resect bones, tough tissues (e.g., cartilage, ligaments), and soft tissues during a surgical procedure; it is not dedicated to a specific clinical application. It includes a mains electricity (AC-powered) control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires).	Obsolete	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143019	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 9.0mm

Device Record Status

Public Device Record Key: 26b5f519-ef8d-4fd1-9927-f2c9c6d0148b
Public Version Date: February 10, 2020
Public Version Number: 5
DI Record Publish Date: April 14, 2016