AccessGUDID - DEVICE: E3D®-C Interbody System (20195860023758)

GUDID

Device Identifier (DI) Information

Brand Name: E3D®-C Interbody System
Version or Model: 130H-S1510
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 130H-S1510
Company Name: Evolution Spine LLC

Primary DI Number: 20195860023758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116940934 *Terms of Use

Device Description: HAnano Integrated Cervical 14'12mm 15Deg 10mm

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?
38161	Metallic spinal interbody fusion cage	A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
ODP	Intervertebral fusion device with bone graft, cervical
OVE	Intervertebral fusion device with integrated fixation, cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K241846	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
Angle: 15 degree
Width: 14 Millimeter
Depth: 12 Millimeter
Height: 10 Millimeter

Device Record Status

Public Device Record Key: 8bf4f439-ca01-478c-958d-32de5aee96ce
Public Version Date: October 14, 2024
Public Version Number: 1
DI Record Publish Date: October 04, 2024