E3D®-C Interbody System

Basic Information

• Brand Name: E3D®-C Interbody System
• Primary DI: 20195860023581
• Version / Model: 130H-S0707
• Catalog Number: 130H-S0707
• Company Name: Evolution Spine LLC
• Labeler DUNS: 116940934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-04
• Public Version: 2
• Public Version Date: 2025-07-14
• Public Version Status: Update
• Public Device Record Key: b65593d1-5c2e-48ab-a513-eab6f4b02a39

Device Description

HAnano Integrated Cervical 14'12mm 7Deg 7mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ODP	Intervertebral fusion device with bone graft, cervical	Orthopedic	888.3080	2
OVE	Intervertebral fusion device with integrated fixation, cervical	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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 typically in the form of a hollow, porous, threaded and/or fenestrated cylindrical, or disc-shaped 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 packaged with the cage.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20195860023581	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K241846	000

Device Sizes

Type	Value	Unit	Text
Height	7	Millimeter
Width	14	Millimeter
Depth	12	Millimeter
Angle	7	degree