MONUMENT

GUDID 00889095085310

MONUMENT Spacer, Large, 8deg, 13mm

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889095085310
• NIH Device Record Key: ef301a79-d78f-4785-9049-2ca5db8d3c4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONUMENT
• Version Model Number: 3108.0713
• 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

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095085310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132559

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00889095085310]

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: 2015-10-30

On-Brand Devices [MONUMENT]

• 00889095170993: MONUMENT DTS Guide, Medial, 13mm
• 00889095170986: MONUMENT DTS Guide, Medial, 11mm
• 00889095170849: MONUMENT Midline Holder Sleeve
• 00889095170832: MONUMENT Midline Implant Holder
• 00889095170665: MONUMENT Trial, Large, 8°, 11mm
• 00889095170658: MONUMENT Trial, Medium, 15°, 21mm
• 00889095085389: MONUMENT Spacer, Large, 15deg, 17mm
• 00889095085372: MONUMENT Spacer, Large, 15deg, 15mm
• 00889095085365: MONUMENT Spacer, Large, 15deg, 13mm
• 00889095085334: MONUMENT Spacer, Large, 8deg, 17mm
• 00889095085327: MONUMENT Spacer, Large, 8deg, 15mm
• 00889095085310: MONUMENT Spacer, Large, 8deg, 13mm
• 00889095085303: MONUMENT Spacer, Large, 8deg, 11mm
• 00889095085273: MONUMENT Spacer, Medium, 15deg, 17mm
• 00889095085266: MONUMENT Spacer, Medium, 15deg, 15mm
• 00889095085259: MONUMENT Spacer, Medium, 15deg, 13mm
• 00889095085242: MONUMENT Spacer, Medium, 15deg, 11mm
• 00889095085211: MONUMENT Spacer, Medium, 8deg, 17mm
• 00889095085204: MONUMENT Spacer, Medium, 8deg, 15mm
• 00889095085198: MONUMENT Spacer, Medium, 8deg, 13mm
• 00889095085181: MONUMENT Spacer, Medium, 8deg, 11mm
• 00889095085150: MONUMENT Spacer, Small, 15deg, 17mm
• 00889095085143: MONUMENT Spacer, Small, 15deg, 15mm
• 00889095085136: MONUMENT Spacer, Small, 15deg, 13mm
• 00889095085129: MONUMENT Spacer, Small, 15deg, 11mm
• 00889095085099: MONUMENT Spacer, Small, 8deg, 17mm
• 00889095085082: MONUMENT Spacer, Small, 8deg, 15mm
• 00889095085075: MONUMENT Spacer, Small, 8deg, 13mm
• 00889095085068: MONUMENT Spacer, Small, 8deg, 11mm