AccessGUDID - DEVICE: CD HORIZON® Spinal System (00643169205741)

GUDID

Device Identifier (DI) Information

Brand Name: CD HORIZON® Spinal System
Version or Model: 5763125
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169205741
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: CONNECTOR 5763125 6.35-6.0 CLSD LAT 25 S

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:	Yes
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?
65114	Bone-screw internal spinal fixation system connector	An implantable, small connecting component of a bone-screw internal spinal fixation system typically in the form of a thin band or small rod with a groove or hole at one or both ends, into which the screw heads and/or primary rods fit, intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. It is designed as a transverse or longitudinal connecting element to be attached to the corresponding screw heads and/or primary rods; it may also have adjustable length and/or angle and/or allow a small amount of screw/rod movement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
OSH	Pedicle screw spinal system, adolescent idiopathic scoliosis
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
MNH	Orthosis, spondylolisthesis spinal fixation
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132328	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 6.0 Millimeter
Length: 25.0 Millimeter
Height: 6.35 Millimeter

Device Record Status

Public Device Record Key: 16d52ae0-7f34-4a12-84a1-79fbcc0feef8
Public Version Date: September 11, 2024
Public Version Number: 5
DI Record Publish Date: July 01, 2015