GATEWAY

GUDID 00849044036640

GATEWAY Thoracolumbar Plate, 64mm

GLOBUS MEDICAL, INC.

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 00849044036640
• NIH Device Record Key: 737d8ba6-7357-4274-bbc4-b07cf47b87f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GATEWAY
• Version Model Number: 129.464
• 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
• 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

• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter
• Length: 64 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044036640 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062407

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

[00849044036640]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-10

On-Brand Devices [GATEWAY]

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• 00849044036770: Single Staple, 7.5mm
• 00849044036763: Single Staple, 6.5mm
• 00849044036756: Single Staple, 5.5mm
• 00849044036749: Single Staple, 5.0mm
• 00849044036732: GATEWAY Thoracolumbar Plate, 100mm
• 00849044036725: GATEWAY Thoracolumbar Plate, 96mm
• 00849044036718: GATEWAY Thoracolumbar Plate, 92mm
• 00849044036701: GATEWAY Thoracolumbar Plate, 88mm
• 00849044036695: GATEWAY Thoracolumbar Plate, 84mm
• 00849044036688: GATEWAY Thoracolumbar Plate, 80mm
• 00849044036671: GATEWAY Thoracolumbar Plate, 76mm
• 00849044036664: GATEWAY Thoracolumbar Plate, 72mm
• 00849044036657: GATEWAY Thoracolumbar Plate, 68mm
• 00849044036640: GATEWAY Thoracolumbar Plate, 64mm
• 00849044036633: GATEWAY Thoracolumbar Plate, 60mm
• 00849044036626: GATEWAY Thoracolumbar Plate, 56mm
• 00849044036619: GATEWAY Thoracolumbar Plate, 52mm
• 00849044036602: GATEWAY Thoracolumbar Plate, 48mm
• 00849044036596: GATEWAY Thoracolumbar Plate, 44mm
• 00849044036589: GATEWAY Thoracolumbar Plate, 42mm
• 00849044036572: GATEWAY Thoracolumbar Plate, 40mm
• 00849044036565: GATEWAY Thoracolumbar Plate, 38mm
• 00849044036558: GATEWAY Thoracolumbar Plate, 36mm
• 00889095038767: 7.5mm Threaded Staple, 3 Prong
• 00889095038750: GATEWAY Thoracolumbar Plate, 34mm
• 00889095038743: GATEWAY Thoracolumbar Plate, 32mm
• 00889095038736: GATEWAY Thoracolumbar Plate, 30mm
• 00889095038729: GATEWAY Thoracolumbar Plate, 28mm
• 00889095038712: GATEWAY Thoracolumbar Plate, 26mm
• 00889095038705: GATEWAY Thoracolumbar Plate, 24mm
• 00889095038699: GATEWAY Thoracolumbar Plate, 22mm
• 00889095038682: GATEWAY Thoracolumbar Plate, 20mm
• 00889095277692: 4.0mm Threaded Staple, 3 Prong
• 00889095277685: 4.5mm Threaded Staple, 3 Prong
• 00889095277678: 5.0mm Threaded Staple, 3 Prong
• 00889095277661: 5.5mm Threaded Staple, 3 Prong
• 00889095277654: 6.0mm Threaded Staple, 3 Prong
• 00889095277647: 6.5mm Threaded Staple, 3 Prong
• 00889095277630: 7.0mm Threaded Staple, 3 Prong