ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology 7116-0510-N

GUDID 00191375036944

Interbody Fusion Device 16 Degree 60 (M/L) 18 (A/P) 10 mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00191375036944
• NIH Device Record Key: 30dc97d1-7b69-46a3-b363-571a18c1e37d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology
• Version Model Number: 7116-0510-N
• Catalog Number: 7116-0510-N
• Company DUNS: 623316978
• Company Name: TITAN SPINE, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(262)242-7801
• Email: productinfo@titanspine.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Length: 60 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Angle: 16 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375036944 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191581

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-24
• Device Publish Date: 2020-08-15

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