Endoskeleton TO 3110-2615-N

GUDID M68231102615N0

Interbody Fusion Device nanoLOCK Surface Technology 0 Degree Convex PLIF 15mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M68231102615N0
• NIH Device Record Key: 22f5f5e7-443e-4917-a536-9dd0c8b9be78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton TO
• Version Model Number: 3110-2615-N
• Catalog Number: 3110-2615-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

Device Dimensions

• Device Size Text, specify: 0
• Height: 15 Millimeter
• Device Size Text, specify: 0
• Depth: 9 Millimeter
• Width: 26 Millimeter
• Device Size Text, specify: 0
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• Width: 26 Millimeter
• 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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• Width: 26 Millimeter
• Device Size Text, specify: 0
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• Width: 26 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Width: 26 Millimeter
• Device Size Text, specify: 0
• Height: 15 Millimeter
• Device Size Text, specify: 0
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• Width: 26 Millimeter
• Device Size Text, specify: 0
• Height: 15 Millimeter
• Device Size Text, specify: 0
• Depth: 9 Millimeter
• Width: 26 Millimeter
• Device Size Text, specify: 0
• Height: 15 Millimeter
• Device Size Text, specify: 0
• Depth: 9 Millimeter
• Width: 26 Millimeter
• Device Size Text, specify: 0
• Height: 15 Millimeter
• Device Size Text, specify: 0
• Depth: 9 Millimeter
• Width: 26 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68231102615N0 [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