FORTIFY

GUDID 00889095046007

FORTIFY 16mm Lower Endplate, 16x45mm Footprint, 0deg

GLOBUS MEDICAL, INC.

Vertebral body prosthesis

• Primary Device ID: 00889095046007
• NIH Device Record Key: 33188b0d-7919-4403-958c-47e799815902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORTIFY
• Version Model Number: 151.881
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Width: 45 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095046007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112756

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[00889095046007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-02-13

On-Brand Devices [FORTIFY]

• 00849044089561: FORTIFY 16mm Upper Endplate, 18x35mm Footprint, 12deg
• 00889095711134: FORTIFY ø12mm Lower Endplate, ø13mm Footprint, 0°
• 00889095639568: T10 Screwdriver, QC, Long
• 00889095639551: T10 Screwdriver, QC, Short
• 00889095639544: Angled Driver Tip, T10
• 00889095610291: FORTIFY ø12mm Variable Angle Upper Endplate, ø13mm Footprint
• 00889095609752: FORTIFY ø16mm Variable Angle Upper Endplate, ø18mm Footprint
• 00889095609745: FORTIFY ø16mm Variable Angle Upper Endplate, ø16mm Footprint
• 00889095609585: FORTIFY ø20mm Variable Angle Upper Endplate, ø20mm Footprint
• 00889095307672: FORTIFY-R 14mm Upper Endplate, 14mm Footprint, 3.5deg, No Spikes
• 00889095307665: FORTIFY 20mm Lower Endplate - 22x40mm, 0deg, No Spikes
• 00889095307658: FORTIFY 20mm Upper Endplate - 22x60mm, 4deg
• 00889095307641: FORTIFY 20mm Upper Endplate - 22x60mm, 0deg
• 00889095307634: FORTIFY 20mm Upper Endplate - 22x55mm, 12deg
• 00889095307627: FORTIFY 20mm Upper Endplate - 22x55mm, 4deg
• 00889095307535: FORTIFY I-R 20mm Core, Height 30-35mm, 21x23mm Footprint, 4°
• 00889095307528: FORTIFY I-R 20mm Core, Height 30-35mm, 21x23mm Footprint, 0°
• 00889095256482: FORTIFY I -R 14mm Upper Endplate, 14x16mm Footprint, 10°, No Spikes
• 00889095256475: FORTIFY I -R 14mm Core, Height 25-29mm, 14x14mm Footprint, 0°, No Spikes
• 00889095220285: FORTIFY-R 20mm Lower Endplate, 20mm Footprint, 16deg
• 00889095220278: FORTIFY I-R 20mm Core, Height 30-35mm, 21x23mm Footprint, 4°, No Spikes
• 00889095220261: FORTIFY I-R 20mm Core, Height 30-35mm, 21x23mm Footprint, 0°, No Spikes
• 00889095218480: FORTIFY-R 20mm Lower Endplate, 25x30mm Footprint, 20deg
• 00889095218473: FORTIFY-R 20mm Lower Endplate, 25x30mm Footprint, 16deg
• 00889095218466: FORTIFY-R 20mm Lower Endplate, 25x30mm Footprint, 12deg
• 00889095218459: FORTIFY-R 20mm Lower Endplate, 25x30mm Footprint, 8deg
• 00889095218442: FORTIFY-R 20mm Lower Endplate, 25x30mm Footprint, 4deg
• 00889095218435: FORTIFY-R 20mm Lower Endplate, 25x30mm Footprint, 4deg, No Spikes
• 00889095218428: FORTIFY-R 20mm Lower Endplate, 25x30mm Footprint, 0deg
• 00889095218411: FORTIFY-R 20mm Lower Endplate, 25x30mm Footprint, 0deg, No Spikes
• 00889095218404: FORTIFY-R 20mm Lower Endplate, 22x26mm Footprint, 20deg
• 00889095218398: FORTIFY-R 20mm Lower Endplate, 22x26mm Footprint, 16deg
• 00889095218381: FORTIFY-R 20mm Lower Endplate, 22x26mm Footprint, 12deg
• 00889095218374: FORTIFY-R 20mm Lower Endplate, 22x26mm Footprint, 8deg
• 00889095218367: FORTIFY-R 20mm Lower Endplate, 22x26mm Footprint, 4deg
• 00889095218350: FORTIFY-R 20mm Lower Endplate, 22x26mm Footprint, 4deg, No Spikes
• 00889095218343: FORTIFY-R 20mm Lower Endplate, 22x26mm Footprint, 0deg
• 00889095218336: FORTIFY-R 20mm Lower Endplate, 22x26mm Footprint, 0deg, No Spikes
• 00889095218329: FORTIFY-R 20mm Lower Endplate, 21x23mm Footprint, 20deg
• 00889095218312: FORTIFY-R 20mm Lower Endplate, 21x23mm Footprint, 16deg
• 00889095218305: FORTIFY-R 20mm Lower Endplate, 21x23mm Footprint, 12deg
• 00889095218299: FORTIFY-R 20mm Lower Endplate, 21x23mm Footprint, 8deg
• 00889095218282: FORTIFY-R 20mm Lower Endplate, 21x23mm Footprint, 4deg
• 00889095218275: FORTIFY-R 20mm Lower Endplate, 21x23mm Footprint, 4deg, No Spikes
• 00889095218268: FORTIFY-R 20mm Lower Endplate, 21x23mm Footprint, 0deg
• 00889095218251: FORTIFY-R 20mm Lower Endplate, 21x23mm Footprint, 0deg, No Spikes
• 00889095218244: FORTIFY-R 20mm Lower Endplate, 20mm Footprint, 20deg
• 00889095218237: FORTIFY-R 20mm Lower Endplate, 20mm Footprint, 12deg
• 00889095218220: FORTIFY-R 20mm Lower Endplate, 20mm Footprint, 8deg
• 00889095218213: FORTIFY-R 20mm Lower Endplate, 20mm Footprint, 4deg