Endoskeleton VBR 2107-0320-N

GUDID M68221070320N0

Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 20mm

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: M68221070320N0
• NIH Device Record Key: b7e92433-e214-436c-bca8-be1e89d63187
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton VBR
• Version Model Number: 2107-0320-N
• Catalog Number: 2107-0320-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: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
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• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 27 Millimeter
• Width: 40 Millimeter
• Angle: 7 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68221070320N0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032812

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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 VBR]

• M68221070320S0: Interbody Fusion Device 7 Degree X-Large 20mm
• M68221070320N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 20mm
• M68221070318S0: Interbody Fusion Device 7 Degree X-Large 18mm
• M68221070318N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree X-Large 18mm
• M68221070220S0: Interbody Fusion Device 7 Degree Large 20mm
• M68221070220N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Large 20mm
• M68221070218S0: Interbody Fusion Device 7 Degree Large 18mm
• M68221070218N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Large 18mm
• M68221070120S0: Interbody Fusion Device 7 Degree Standard 20mm
• M68221070120N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Standard 20mm
• M68221070118S0: Interbody Fusion Device 7 Degree Standard 18mm
• M68221070118N0: Interbody Fusion Device nanoLOCK Surface Technology 7 Degree Standard 18mm
• M682210703200: Interbody Fusion Device 7 Degree X-Large 20mm
• M682210703180: Interbody Fusion Device 7 Degree X-Large 18mm
• M682210702200: Interbody Fusion Device 7 Degree Large 20mm
• M682210702180: Interbody Fusion Device 7 Degree Large 18mm
• M682210701200: Interbody Fusion Device 7 Degree Standard 20mm
• M682210701180: Interbody Fusion Device 7 Degree Standard 18mm