Endoskeleton TC 5160-1411-N

GUDID M68251601411N0

Interbody Fusion Device nanoLOCK Surface Technology Parallel Medium 11mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M68251601411N0
• NIH Device Record Key: 5523c17e-7f61-47b4-ab18-41f5b58cedb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton TC
• Version Model Number: 5160-1411-N
• Catalog Number: 5160-1411-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(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(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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Depth: 14 Millimeter
• Width: 16 Millimeter
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• Device Size Text, specify: 0
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• Depth: 14 Millimeter
• Width: 16 Millimeter
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• Device Size Text, specify: 0
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• Width: 16 Millimeter
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Depth: 14 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Depth: 14 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Depth: 14 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Depth: 14 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Depth: 14 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Depth: 14 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Depth: 14 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 11 Millimeter
• Depth: 14 Millimeter
• Width: 16 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68251601411N0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100889

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-17

On-Brand Devices [Endoskeleton TC]

• M682520010010: INSERTER
• M68251861612S0: Interbody Fusion Device 6 Degree Large 12mm
• M68251861612N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 12mm
• M68251861611S0: Interbody Fusion Device 6 Degree Large 11mm
• M68251861611N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 11mm
• M68251861610S0: Interbody Fusion Device 6 Degree Large 10mm
• M68251861610N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 10mm
• M68251861609S0: Interbody Fusion Device 6 Degree Large 9mm
• M68251861609N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 9mm
• M68251861608S0: Interbody Fusion Device 6 Degree Large 8mm
• M68251861608N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 8mm
• M68251861607S0: Interbody Fusion Device 6 Degree Large 7mm
• M68251861607N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 7mm
• M68251861606S0: Interbody Fusion Device 6 Degree Large 6mm
• M68251861606N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 6mm
• M68251861605S0: Interbody Fusion Device 6 Degree Large 5mm
• M68251861605N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 5mm
• M68251801612S0: Interbody Fusion Device Parallel Large 12mm
• M68251801612N0: Interbody Fusion Device nanoLOCK Surface Technology Parallel Large 12mm
• M68251801611S0: Interbody Fusion Device Parallel Large 11mm
• M68251801611N0: Interbody Fusion Device nanoLOCK Surface Technology Parallel Large 11mm
• M68251801610S0: Interbody Fusion Device Parallel Large 10mm
• M68251801610N0: Interbody Fusion Device nanoLOCK Surface Technology Parallel Large 10mm
• M68251801609S0: Interbody Fusion Device Parallel Large 9mm
• M68251801609N0: Interbody Fusion Device nanoLOCK Surface Technology Parallel Large 9mm
• M68251801608S0: Interbody Fusion Device Parallel Large 8mm
• M68251801608N0: Interbody Fusion Device nanoLOCK Surface Technology Parallel Large 8mm
• M68251801607S0: Interbody Fusion Device Parallel Large 7mm
• M68251801607N0: Interbody Fusion Device nanoLOCK Surface Technology Parallel Large 7mm
• M68251801606S0: Interbody Fusion Device Parallel Large 6mm
• M68251801606N0: Interbody Fusion Device nanoLOCK Surface Technology Parallel Large 6mm
• M68251801605S0: Interbody Fusion Device Parallel Large 5mm
• M68251801605N0: Interbody Fusion Device nanoLOCK Surface Technology Parallel Large 5mm
• M68251661412S0: Interbody Fusion Device 6 Degree Medium 12mm
• M68251661412N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Medium 12mm
• M68251661411S0: Interbody Fusion Device 6 Degree Medium 11mm
• M68251661411N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Medium 11mm
• M68251661410S0: Interbody Fusion Device 6 Degree Medium 10mm
• M68251661410N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Medium 10mm
• M68251661409S0: Interbody Fusion Device 6 Degree Medium 9mm
• M68251661409N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Medium 9mm
• M68251661408S0: Interbody Fusion Device 6 Degree Medium 8mm
• M68251661408N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Medium 8mm
• M68251661407S0: Interbody Fusion Device 6 Degree Medium 7mm
• M68251661407N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Medium 7mm
• M68251661406S0: Interbody Fusion Device 6 Degree Medium 6mm
• M68251661406N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Medium 6mm
• M68251661405S0: Interbody Fusion Device 6 Degree Medium 5mm
• M68251661405N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Medium 5mm
• M68251601412S0: Interbody Fusion Device Parallel Medium 12mm