Fortilink Cages with TiPlus Technology

Basic Information

• Brand Name: Fortilink Cages with TiPlus Technology
• Primary DI: 08720246787078
• Version / Model: Fortilink®-A
• Catalog Number: 67-A-3627-14-20L
• Company Name: Baat Medical Products B.V.
• Labeler DUNS: 413205480
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-17
• Public Version: 1
• Public Version Date: 2021-11-25
• Public Version Status: New
• Public Device Record Key: 355486ec-399b-42dd-8569-67a04c176b1a

Device Description

Anterior Lumbar Cage

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

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
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720246787078	GS1

Premarket Submissions

Submission Number	Supplement Number
K201453	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			36x27x14mm
Angle	20	degree

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: The products shall be stored and handled with care. The primary, secondary and eventual tertiary packaging shall remain intact at all times. The products shall be kept dry and stored and handled in an