Endoskeleton TC 5180-1606-S

GUDID M68251801606S0

Interbody Fusion Device Parallel Large 6mm

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 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: M68251801606S0
• NIH Device Record Key: cad6c73e-573d-41ee-8de2-9fd568d31c11
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton TC
• Version Model Number: 5180-1606-S
• Catalog Number: 5180-1606-S
• 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

Device Dimensions

• Height: 6 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter
• Device Size Text, specify: 0
• Height: 6 Millimeter
• Width: 18 Millimeter
• Device Size Text, specify: 0
• Depth: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68251801606S0 [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

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• 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