Endoskeleton TT 4110-3007-S

GUDID M68241103007S0

Interbody Fusion Device Parallel Large 7mm

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: M68241103007S0
• NIH Device Record Key: f4dac74e-4380-4866-a2cd-e674a0112836
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton TT
• Version Model Number: 4110-3007-S
• Catalog Number: 4110-3007-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

• Device Size Text, specify: 0
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
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• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
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• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
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• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
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• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter
• Height: 7 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Width: 30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68241103007S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083714

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 TT]

• 00191375025719: ARTICULATING INSERTER TRAY SYSTEM
• 00191375025702: Articulating Inserter, X-Large
• M682420010460: Articulating Inserter, X-Large
• M682420010400: CURVED, INSERTER
• M682420010210: THIN, PUSHER
• M682420010030: STRAIGHT, PUSHER
• M682420010010: STRAIGHT, INSERTER
• M682420010190: LARGE, DOWN ANGLED, CURETTE
• M682420010180: LARGE, LEFT ANGLED, CURETTE
• M682420010170: LARGE, RIGHT ANGLED, CURETTE
• M682420010160: LARGE, STRAIGHT, CURETTE
• M682420010100: CONE RING, CURETTE
• M68241143514S0: Interbody Fusion Device 4 Degree X-Large 14mm
• M68241143514N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 14mm
• M68241143513S0: Interbody Fusion Device 4 Degree X-Large 13mm
• M68241143513N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 13mm
• M68241143512S0: Interbody Fusion Device 4 Degree X-Large 12mm
• M68241143512N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 12mm
• M68241143511S0: Interbody Fusion Device 4 Degree X-Large 11mm
• M68241143511N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 11mm
• M68241143510S0: Interbody Fusion Device 4 Degree X-Large 10mm
• M68241143510N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 10mm
• M68241143509S0: Interbody Fusion Device 4 Degree X-Large 9mm
• M68241143509N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 9mm
• M68241143508S0: Interbody Fusion Device 4 Degree X-Large 8mm
• M68241143508N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree X-Large 8mm
• M68241143014S0: Interbody Fusion Device 4 Degree Large 14mm
• M68241143014N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 14mm
• M68241143013S0: Interbody Fusion Device 4 Degree Large 13mm
• M68241143013N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 13mm
• M68241143012S0: Interbody Fusion Device 4 Degree Large 12mm
• M68241143012N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 12mm
• M68241143011S0: Interbody Fusion Device 4 Degree Large 11mm
• M68241143011N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 11mm
• M68241143010S0: Interbody Fusion Device 4 Degree Large 10mm
• M68241143010N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 10mm
• M68241143009S0: Interbody Fusion Device 4 Degree Large 9mm
• M68241143009N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 9mm
• M68241143008S0: Interbody Fusion Device 4 Degree Large 8mm
• M68241143008N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Large 8mm
• M68241142514S0: Interbody Fusion Device 4 Degree Standard 14mm
• M68241142514N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Standard 14mm
• M68241142513S0: Interbody Fusion Device 4 Degree Standard 13mm
• M68241142513N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Standard 13mm
• M68241142512S0: Interbody Fusion Device 4 Degree Standard 12mm
• M68241142512N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Standard 12mm
• M68241142511S0: Interbody Fusion Device 4 Degree Standard 11mm
• M68241142511N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Standard 11mm
• M68241142510S0: Interbody Fusion Device 4 Degree Standard 10mm
• M68241142510N0: Interbody Fusion Device nanoLOCK Surface Technology 4 Degree Standard 10mm