ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology 7116-0312-N

GUDID 00191375037026

Interbody Fusion Device 16 Degree 50 (M/L) 18 (A/P) 12 mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00191375037026
• NIH Device Record Key: 5aec4867-aab1-41e0-ae09-ef80fc3f8dd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TL Hyperlordotic nanoLOCK® Surface Technology
• Version Model Number: 7116-0312-N
• Catalog Number: 7116-0312-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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 50 Millimeter
• Height: 12 Millimeter
• Angle: 16 degree
• Width: 18 Millimeter
• 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	00191375037026 [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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• 00191375050131: Interbody Fusion Device 30 Degree 50 (M/L) 22 (A/P) 19 mm
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• 00191375050070: Interbody Fusion Device 30 Degree 45 (M/L) 22 (A/P) 18 mm
• 00191375050063: Interbody Fusion Device 30 Degree 45 (M/L) 22 (A/P) 17 mm
• 00191375050056: Interbody Fusion Device 30 Degree 45 (M/L) 22 (A/P) 16 mm
• 00191375050049: Interbody Fusion Device 30 Degree 40 (M/L) 22 (A/P) 20 mm
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