ENDOSKELETON® TL nanoLOCK® Surface Technology 7100-1410-N

GUDID 00191375014898

Interbody Fusion Device Parallel 55 (M/L) 22 (A/P) 10 mm

TITAN SPINE, LLC

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• Primary Device ID: 00191375014898
• NIH Device Record Key: 86fbea80-ecbd-4078-999f-5ca2cffc02df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TL nanoLOCK® Surface Technology
• Version Model Number: 7100-1410-N
• Catalog Number: 7100-1410-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

Device Dimensions

• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Device Size Text, specify: 0
• Width: 22 Millimeter
• Length: 55 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375014898 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140055

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-12-15

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