Endoskeleton TO 3114-3114-N

GUDID M68231143114N0

Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Oblique 14mm

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 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: M68231143114N0
• NIH Device Record Key: fe66f657-cf3d-4a45-9caa-0e823b81e8b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton TO
• Version Model Number: 3114-3114-N
• Catalog Number: 3114-3114-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
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Height: 14 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68231143114N0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102067

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: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-17

On-Brand Devices [Endoskeleton TO]

• M682320040000: THREADED, IMPLANT REMOVER
• M68231143116S0: Interbody Fusion Device 4 Degree Oblique 16mm
• M68231143116N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Oblique 16mm
• M68231143115S0: Interbody Fusion Device 4 Degree Oblique 15mm
• M68231143115N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Oblique 15mm
• M68231143114S0: Interbody Fusion Device 4 Degree Oblique 14mm
• M68231143114N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Oblique 14mm
• M68231143113S0: Interbody Fusion Device 4 Degree Oblique 13mm
• M68231143113N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Oblique 13mm
• M68231143112S0: Interbody Fusion Device 4 Degree Oblique 12mm
• M68231143112N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Oblique 12mm
• M68231143111S0: Interbody Fusion Device 4 Degree Oblique 11mm
• M68231143111N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Oblique 11mm
• M68231143110S0: Interbody Fusion Device 4 Degree Oblique 10mm
• M68231143110N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Oblique 10mm
• M68231143109S0: Interbody Fusion Device 4 Degree Oblique 9mm
• M68231143109N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Oblique 9mm
• M68231143108S0: Interbody Fusion Device 4 Degree Oblique 8mm
• M68231143108N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Oblique 8mm
• M68231142616S0: Interbody Fusion Device 4 Degree PLIF 16mm
• M68231142616N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 16mm
• M68231142615S0: Interbody Fusion Device 4 Degree PLIF 15mm
• M68231142615N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 15mm
• M68231142614S0: Interbody Fusion Device 4 Degree PLIF 14mm
• M68231142614N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 14mm
• M68231142613S0: Interbody Fusion Device 4 Degree PLIF 13mm
• M68231142613N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 13mm
• M68231142612S0: Interbody Fusion Device 4 Degree PLIF 12mm
• M68231142612N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 12mm
• M68231142611S0: Interbody Fusion Device 4 Degree PLIF 11mm
• M68231142611N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 11mm
• M68231142610S0: Interbody Fusion Device 4 Degree PLIF 10mm
• M68231142610N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 10mm
• M68231142609S0: Interbody Fusion Device 4 Degree PLIF 9mm
• M68231142609N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 9mm
• M68231142608S0: Interbody Fusion Device 4 Degree PLIF 8mm
• M68231142608N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 8mm
• M68231142216S0: Interbody Fusion Device 4 Degree PLIF 16mm
• M68231142216N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 16mm
• M68231142215S0: Interbody Fusion Device 4 Degree PLIF 15mm
• M68231142215N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 15mm
• M68231142214S0: Interbody Fusion Device 4 Degree PLIF 14mm
• M68231142214N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 14mm
• M68231142213S0: Interbody Fusion Device 4 Degree PLIF 13mm
• M68231142213N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 13mm
• M68231142212S0: Interbody Fusion Device 4 Degree PLIF 12mm
• M68231142212N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 12mm
• M68231142211S0: Interbody Fusion Device 4 Degree PLIF 11mm
• M68231142211N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree PLIF 11mm
• M68231142210S0: Interbody Fusion Device 4 Degree PLIF 10mm