Endoskeleton TC 5140-1211

GUDID M682514012110

Interbody Fusion Device Parallel Small 11mm

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

• Primary Device ID: M682514012110
• NIH Device Record Key: ab09f0b9-d71b-458c-8d06-c0217f2a6739
• Commercial Distribution Discontinuation: 2020-09-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Endoskeleton TC
• Version Model Number: 5140-1211
• Catalog Number: 5140-1211
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Dimensions

• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 12 Millimeter
• Width: 14 Millimeter
• Height: 11 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 12 Millimeter
• Width: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M682514012110 [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: true
• Device Is Sterile: false

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

[M682514012110]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• 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