AccessGUDID - DEVICE: CD HORIZON® Spinal System (00613994846594)

GUDID

Device Identifier (DI) Information

Brand Name: CD HORIZON® Spinal System
Version or Model: X0410125
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00613994846594
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: INSERTER X0410125 ROD LONG COLLET

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?
44869	Orthopaedic graft inserter, reusable	A hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K102807	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
No Device Sizes

Device Record Status

Public Device Record Key: 1c3c48d2-eeac-4a96-8d6a-2539c050c88b
Public Version Date: August 20, 2024
Public Version Number: 4
DI Record Publish Date: September 09, 2015