REVOLVE

GUDID 00849044071726

5.5mm REVOLVE Monoaxial Screw, 55mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00849044071726
• NIH Device Record Key: 74180373-6d97-4ba5-bd4b-ba8b5b3c4d68
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVOLVE
• Version Model Number: 585.357
• 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

• Outer Diameter: 5.5 Millimeter
• Outer Diameter: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044071726 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111449

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[00849044071726]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-28

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• 00849044072594: 5.5mm REVOLVE Rod, CoCr, 180mm
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• 00849044072501: 5.5mm REVOLVE Rod, CoCr, 80mm
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