ENDOSKELETON® TA VBR Sterile Barrier System 2107-0320-S

GUDID 00191375018896

Interbody Fusion Device 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

• Primary Device ID: 00191375018896
• NIH Device Record Key: c15c5ce6-ebe0-4891-ac33-39d1a7ec2237
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TA VBR Sterile Barrier System
• Version Model Number: 2107-0320-S
• Catalog Number: 2107-0320-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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375018896 [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: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-12-15

On-Brand Devices [ENDOSKELETON® TA VBR Sterile Barrier System]

• 00191375018896: Interbody Fusion Device 7 Degree X-Large 20mm
• 00191375018889: Interbody Fusion Device 7 Degree X-Large 18mm
• 00191375018872: Interbody Fusion Device 7 Degree Large 20mm
• 00191375018865: Interbody Fusion Device 7 Degree Large 18mm
• 00191375018858: Interbody Fusion Device 7 Degree Standard 20mm
• 00191375018841: Interbody Fusion Device 7 Degree Standard 18mm