SECURE-C

GUDID 00889095179170

SECURE-C Endplate Assembly, 15x18mm, 0°

GLOBUS MEDICAL, INC.

Cervical total disc replacement prosthesis

• Primary Device ID: 00889095179170
• NIH Device Record Key: d8c07912-26f8-426a-8f34-4447207729d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SECURE-C
• Version Model Number: 714.400S
• 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

Customer Support Contacts

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

Device Dimensions

• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter
• Depth: 15 Millimeter
• Width: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095179170 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100003

FDA Product Code

• MJO: PROSTHESIS, INTERVERTEBRAL DISC

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: 2020-04-06
• Device Publish Date: 2015-10-01

On-Brand Devices [SECURE-C]

• 00889095179200: SECURE-C Endplate & Core Assembly, 15x18mm, 0°, 6mm
• 00889095179194: SECURE-C Endplate & Core Assembly, 15x18mm, 6°, 6mm
• 00889095179187: SECURE-C Endplate Assembly, 15x18mm, 6°
• 00889095179170: SECURE-C Endplate Assembly, 15x18mm, 0°
• 00889095179163: SECURE-C Endplate & Core Assembly, 14x16, 0°, 6mm
• 00889095179156: SECURE-C Endplate & Core Assembly, 14x16, 6°, 6mm
• 00889095179149: SECURE-C Endplate Assembly, 14x16, 6°
• 00889095179132: SECURE-C Endplate Assembly, 14x16, 0°
• 00889095179125: SECURE-C Endplate & Core Assembly, 13x14, 0°, 6mm
• 00889095179118: SECURE-C Endplate & Core Assembly, 13x14, 6°, 6mm
• 00889095179101: SECURE-C Endplate Assembly, 13x14, 6°
• 00889095179095: SECURE-C Endplate Assembly, 13x14, 0°
• 00889095179088: SECURE-C Endplate & Core Assembly, 11x12, 0°, 6mm
• 00889095179071: SECURE-C Endplate & Core Assembly, 11x12, 6°, 6mm
• 00889095179064: SECURE-C Endplate Assembly, 11x12, 6°
• 00889095179057: SECURE-C Endplate Assembly, 11x12, 0°
• 00889095154962: SECURE-C Core, 14x16, 12mm
• 00889095154955: SECURE-C Core, 14x16, 11mm
• 00889095154948: SECURE-C Core, 14x16, 10mm
• 00889095154931: SECURE-C Core, 14x16, 9mm
• 00889095154924: SECURE -C Core 14x16, 8mm
• 00889095154917: SECURE-C Core, 14x16, 7mm
• 00889095154900: SECURE-C Core, 13x14, 12mm
• 00889095154894: SECURE-C Core, 13x14, 11mm
• 00889095154887: SECURE-C Core, 13x14, 10mm
• 00889095154870: SECURE-C Core, 13x14, 9mm
• 00889095154863: SECURE-C Core, 13x14, 8mm
• 00889095154856: SECURE-C Core, 13x14, 7mm
• 00889095154849: SECURE-C Core, 11x12, 12mm
• 00889095154832: SECURE-C Core, 11x12, 11mm
• 00889095154825: SECURE-C Core, 11x12, 10mm
• 00889095154818: SECURE-C Core, 11x12, 9mm
• 00889095154801: SECURE-C Core, 11x12, 8mm
• 00889095154795: SECURE-C Core, 11x12, 7mm