ENDOSKELETON® TA Sterile Barrier System 2107-0116-S

GUDID 00191375018964

Interbody Fusion Device 7 Degree Standard 16mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00191375018964
• NIH Device Record Key: 914eae95-abcd-4c9d-9e2c-7b9bc88be774
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TA Sterile Barrier System
• Version Model Number: 2107-0116-S
• Catalog Number: 2107-0116-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
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Depth: 21 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Height: 16 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375018964 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080615

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: 6
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-12-15

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

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• 00191375019121: Interbody Fusion Device 7 Degree X-Large 16mm
• 00191375019114: Interbody Fusion Device 7 Degree X-Large 15mm
• 00191375019107: Interbody Fusion Device 7 Degree X-Large 14mm
• 00191375019091: Interbody Fusion Device 7 Degree X-Large 13mm
• 00191375019084: Interbody Fusion Device 7 Degree X-Large 12mm
• 00191375019077: Interbody Fusion Device 7 Degree X-Large 11mm
• 00191375019060: Interbody Fusion Device 7 Degree X-Large 10mm
• 00191375019053: Interbody Fusion Device 7 Degree Large 17mm
• 00191375019046: Interbody Fusion Device 7 Degree Large 16mm
• 00191375019039: Interbody Fusion Device 7 Degree Large 15mm
• 00191375019022: Interbody Fusion Device 7 Degree Large 14mm
• 00191375019015: Interbody Fusion Device 7 Degree Large 13mm
• 00191375019008: Interbody Fusion Device 7 Degree Large 12mm
• 00191375018995: Interbody Fusion Device 7 Degree Large 11mm
• 00191375018988: Interbody Fusion Device 7 Degree Large 10mm
• 00191375018971: Interbody Fusion Device 7 Degree Standard 17mm
• 00191375018964: Interbody Fusion Device 7 Degree Standard 16mm
• 00191375018957: Interbody Fusion Device 7 Degree Standard 15mm
• 00191375018940: Interbody Fusion Device 7 Degree Standard 14mm
• 00191375018933: Interbody Fusion Device 7 Degree Standard 13mm
• 00191375018926: Interbody Fusion Device 7 Degree Standard 12mm
• 00191375018919: Interbody Fusion Device 7 Degree Standard 11mm
• 00191375018902: Interbody Fusion Device 7 Degree Standard 10mm