CONCORD

GUDID 00889095358247

FORTRESS-Plus Radiopaque Bone Cement, 40g

GLOBUS MEDICAL, INC.

Orthopaedic cement, non-antimicrobial

• Primary Device ID: 00889095358247
• NIH Device Record Key: 57b779e9-4cc4-4389-b680-afbf5f707ca6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONCORD
• Version Model Number: 4129.4040S
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095358247 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162618

FDA Product Code

• NDN: CEMENT, BONE, VERTEBROPLASTY

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-09
• Device Publish Date: 2024-12-01

On-Brand Devices [CONCORD]

• 00889095358247: FORTRESS-Plus Radiopaque Bone Cement, 40g
• 00889095358230: FORTRESS-Plus Radiopaque Bone Cement, 20g