Elite Expandable Interbody Fusion Device

Basic Information

• Brand Name: Elite Expandable Interbody Fusion Device
• Primary DI: M7405410405
• Version / Model: 10-10-74-21
• Catalog Number: 541-0405
• Company Name: SPINEOLOGY INC.
• Labeler DUNS: 033014361
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-03
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1c7a2506-dbdb-44d4-9969-442e06137181

Device Description

12mm Elite Expandable

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: MR Unsafe
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MAX	Intervertebral fusion device with bone graft, lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57805	Metallic spinal fusion cage, non-sterile	A non-sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) made of metal [usually titanium (Ti)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for therapeutic spinal bone fusion to occur. Disposable devices associated with implantation may be included. This device must be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M7405410405	HIBCC

Customer Contacts

• Phone: [phone] ext. 534
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K162879	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			12 x 29/32, 6°
Width	12	Millimeter