Endoskeleton VBR 2107-0320

GUDID M682210703200

Interbody Fusion Device 7 Degree X-Large 20mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M682210703200
• NIH Device Record Key: 7f261381-8144-4fde-a586-4d10287c7a5b
• Commercial Distribution Discontinuation: 2020-09-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Endoskeleton VBR
• Version Model Number: 2107-0320
• Catalog Number: 2107-0320
• 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

• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter
• Device Size Text, specify: 0
• Height: 20 Millimeter
• Angle: 7 degree
• Depth: 27 Millimeter
• Device Size Text, specify: 0
• Width: 40 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M682210703200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032812

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

Moist Heat or Steam Sterilization

[M682210703200]

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 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