ENDOSKELETON® TC Sterile Barrier System

Basic Information

• Brand Name: ENDOSKELETON® TC Sterile Barrier System
• Primary DI: 00191375019671
• Version / Model: 5160-1405-S
• Catalog Number: 5160-1405-S
• Company Name: TITAN SPINE, LLC
• Labeler DUNS: 623316978
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-15
• Public Version: 9
• Public Version Date: 2020-12-09
• Public Version Status: Update
• Public Device Record Key: 4337389a-cc08-4c7e-b7dc-860a2f5fa070
• Distribution End Date: 2020-09-18

Device Description

Interbody Fusion Device Parallel Medium 5mm

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: 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: 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

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	00191375019671	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K100889	000
K142589	000

Device Sizes

Type	Value	Unit	Text
Width	16	Millimeter
Device Size Text, specify			width(MLxAP), 16 x 14, mm
Depth	14	Millimeter
Device Size Text, specify			Parallel
Height	5	Millimeter