T-PAL™ ProTi 360°™ 108812212

GUDID 00819917021783

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00819917021783
• NIH Device Record Key: f79ea031-9d3d-4f34-8214-009834fcc92f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-PAL™ ProTi 360°™
• Version Model Number: 108812212
• Catalog Number: 108812212
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• Device Count: 1
• DM Exempt: false
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819917021783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172185

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-04-14

On-Brand Devices [T-PAL™ ProTi 360°™]

• 00819917021837: 108812217
• 00819917021820: 108812216
• 00819917021813: 108812215
• 00819917021806: 108812214
• 00819917021790: 108812213
• 00819917021783: 108812212
• 00819917021776: 108812211
• 00819917021769: 108812210
• 00819917021752: 108812209
• 00819917021745: 108812208
• 00819917021738: 108812207
• 00819917021721: 108812017
• 00819917021714: 108812016
• 00819917021707: 108812015
• 00819917021691: 108812014
• 00819917021684: 108812013
• 00819917021677: 108812012
• 00819917021660: 108812011
• 00819917021653: 108812010
• 00819917021646: 108812009
• 00819917021639: 108812008
• 00819917021622: 108812007