AccessGUDID - DEVICE: Divergence® Anterior Cervical Fusion System (00643169336698)

GUDID

Device Identifier (DI) Information

Brand Name: Divergence® Anterior Cervical Fusion System
Version or Model: G7736767
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC SOFAMOR DANEK, INC.

Primary DI Number: 00643169336698
Issuing Agency: GS1
Commercial Distribution End Date: September 26, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 830350380 *Terms of Use

Device Description: IMPLANT G7736767 MP LORDO 7MMX17MMX16MM

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?
44692	Spinal fusion graft kit	A collection of sterile devices used to induce new spinal bone tissue that consists of a metallic spinal fusion cage, a recombinant human bone morphogenetic protein, and a carrier/scaffold for the protein and resulting bone growth. The bone morphogenetic protein is placed on the carrier/scaffold which is inserted into the spinal fusion cage. The spinal fusion cage is implanted into the spine and new bone tissue is induced at the site of implantation. The device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD). This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
ODP	Intervertebral fusion device with bone graft, cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140417	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
Depth: 13.4 Millimeter
Width: 17.0 Millimeter
Angle: 6.0 degree
Height: 7.0 Millimeter

Device Record Status

Public Device Record Key: 97ec7b63-06eb-4128-bfc1-7dbef8025941
Public Version Date: November 28, 2022
Public Version Number: 4
DI Record Publish Date: April 14, 2016