InTice™ -C Porous Ti Cervical Interbody System

GUDID M697X0980306STR1

InTice™-C 15mm x 18mm x 6mm x 7° Lordotic

X-SPINE SYSTEMS, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: M697X0980306STR1
• NIH Device Record Key: 4cd17935-d5f4-4fe2-8e43-e18e48b81e9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InTice™ -C Porous Ti Cervical Interbody System
• Version Model Number: X098-0306-STR
• Company DUNS: 610042587
• Company Name: X-SPINE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: 1(888)886-9354
• Email: CS@xtantmedical.com

Device Dimensions

• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter
• Angle: 7 degree
• Height: 6 Millimeter
• Width: 18 Millimeter
• Length: 15 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697X0980306STR1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173832

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-11-05

On-Brand Devices [InTice™ -C Porous Ti Cervical Interbody System]

• M697X0980407STR1: InTice™-C 11mm x 14mm x 7mm Parallel-Convex
• M697X0980406STR1: InTice™-C 11mm x 14mm x 6mm Parallel-Convex
• M697X0980405STR1: InTice™-C 11mm x 14mm x 5mm Parallel-Convex
• M697X0980312STR1: InTice™-C 15mm x 18mm x 12mm x 7° Lordotic
• M697X0980311STR1: InTice™-C 15mm x 18mm x 11mm x 7° Lordotic
• M697X0980310STR1: InTice™-C 15mm x 18mm x 10mm x 7° Lordotic
• M697X0980309STR1: InTice™-C 15mm x 18mm x 9mm x 7° Lordotic
• M697X0980308STR1: InTice™-C 15mm x 18mm x 8mm x 7° Lordotic
• M697X0980307STR1: InTice™-C 15mm x 18mm x 7mm x 7° Lordotic
• M697X0980306STR1: InTice™-C 15mm x 18mm x 6mm x 7° Lordotic
• M697X0980305STR1: InTice™-C 15mm x 18mm x 5mm x 7° Lordotic
• M697X0980212STR1: InTice™-C 13mm x 16mm x 12mm x 7° Lordotic
• M697X0980211STR1: InTice™-C 13mm x 16mm x 11mm x 7° Lordotic
• M697X0980210STR1: InTice™-C 13mm x 16mm x 10mm x 7° Lordotic
• M697X0980209STR1: InTice™-C 13mm x 16mm x 9mm x 7° Lordotic
• M697X0980208STR1: InTice™-C 13mm x 16mm x 8mm x 7° Lordotic
• M697X0980207STR1: InTice™-C 13mm x 16mm x 7mm x 7° Lordotic
• M697X0980206STR1: InTice™-C 13mm x 16mm x 6mm x 7° Lordotic
• M697X0980205STR1: InTice™-C 13mm x 16mm x 5mm x 7° Lordotic
• M697X0980112STR1: InTice™-C 11mm x 14mm x 12mm x 7° Lordotic
• M697X0980111STR1: InTice™-C 11mm x 14mm x 11mm x 7° Lordotic
• M697X0980110STR1: InTice™-C 11mm x 14mm x 10mm x 7° Lordotic
• M697X0980109STR1: InTice™-C 11mm x 14mm x 9mm x 7° Lordotic
• M697X0980108STR1: InTice™-C 11mm x 14mm x 8mm x 7° Lordotic
• M697X0980107STR1: InTice™-C 11mm x 14mm x 7mm x 7° Lordotic
• M697X0980106STR1: InTice™-C 11mm x 14mm x 6mm x 7° Lordotic
• M697X0980105STR1: InTice™-C 11mm x 14mm x 5mm x 7° Lordotic
• M697X0980612STR1: InTice™-C 15mm x 18mm x 12mm Parallel-Convex
• M697X0980611STR1: InTice™-C 15mm x 18mm x 11mm Parallel-Convex
• M697X0980610STR1: InTice™-C 15mm x 18mm x 10mm Parallel-Convex
• M697X0980609STR1: InTice™-C 15mm x 18mm x 9mm Parallel-Convex
• M697X0980608STR1: InTice™-C 15mm x 18mm x 8mm Parallel-Convex
• M697X0980607STR1: InTice™-C 15mm x 18mm x 7mm Parallel-Convex
• M697X0980606STR1: InTice™-C 15mm x 18mm x 6mm Parallel-Convex
• M697X0980605STR1: InTice™-C 15mm x 18mm x 5mm Parallel-Convex
• M697X0980512STR1: InTice™-C 13mm x 16mm x 12mm Parallel-Convex
• M697X0980511STR1: InTice™-C 13mm x 16mm x 11mm Parallel-Convex
• M697X0980510STR1: InTice™-C 13mm x 16mm x 10mm Parallel-Convex
• M697X0980509STR1: InTice™-C 13mm x 16mm x 9mm Parallel-Convex
• M697X0980508STR1: InTice™-C 13mm x 16mm x 8mm Parallel-Convex
• M697X0980507STR1: InTice™-C 13mm x 16mm x 7mm Parallel-Convex
• M697X0980506STR1: InTice™-C 13mm x 16mm x 6mm Parallel-Convex
• M697X0980505STR1: InTice™-C 13mm x 16mm x 5mm Parallel-Convex
• M697X0980412STR1: InTice™-C 11mm x 14mm x 12mm Parallel-Convex
• M697X0980411STR1: InTice™-C 11mm x 14mm x 11mm Parallel-Convex
• M697X0980410STR1: InTice™-C 11mm x 14mm x 10mm Parallel-Convex
• M697X0980409STR1: InTice™-C 11mm x 14mm x 9mm Parallel-Convex
• M697X0980408STR1: InTice™-C 11mm x 14mm x 8mm Parallel-Convex