AccessGUDID - DEVICE: CD HORIZON® Spinal System (00643169468672)

GUDID

Device Identifier (DI) Information

Brand Name: CD HORIZON® Spinal System
Version or Model: X1013206
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169468672
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: SCREWDRIVER X1013206 6.35MM MAS

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):	Yes
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?
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

FDA Product Code

[?]

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

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: 6.35mm

Device Record Status

Public Device Record Key: e0be9f53-85a3-4996-8d20-0b4a7476d099
Public Version Date: September 19, 2024
Public Version Number: 6
DI Record Publish Date: July 04, 2016