EXCELSIUSFLEX

GUDID 00193982565428

ExcelsiusFlex, 120V

GLOBUS MEDICAL, INC.

Robotic surgical navigation system

• Primary Device ID: 00193982565428
• NIH Device Record Key: cfdcb5c1-ecda-476d-bb73-784ee968b7aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXCELSIUSFLEX
• Version Model Number: 6258.1001
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193982565428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240721

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [EXCELSIUSFLEX]

• 00193982567910: Articulated Driver Tip
• 00193982567903: CT Registration Attachment, EFlex
• 00193982567897: Plane Checker Attachment, EFlex
• 00193982567880: Sawblade Calibration Attachment, EFlex
• 00193982567873: Tibia Hook Attachment, EFlex
• 00193982567866: Implant Verification Attachment, EFlex
• 00193982567859: Registration Stylus, EFlex
• 00193982567842: Quick-Connect Array, EFlex
• 00193982567835: Tibia Reference Array, EFlex
• 00193982567828: Femur Reference Array, EFlex
• 00193982567811: Robot Reference Array, EFlex
• 00193982567774: Sawblade Adapter, EFlex
• 00193982567767: End Effector Base Lock, EFlex
• 00193982565428: ExcelsiusFlex, 120V