ENDOSKELETON® TAS Hyperlordotic Sterile Barrier System 2316-0218-S

GUDID 00191375026716

Interbody Fusion Device 16 Degree Large 18mm

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: 00191375026716
• NIH Device Record Key: 6ee01d45-93f6-4fcc-bd1a-17ea599a010a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TAS Hyperlordotic Sterile Barrier System
• Version Model Number: 2316-0218-S
• Catalog Number: 2316-0218-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

• Height: 18 Millimeter
• Height: 18 Millimeter
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter
• Angle: 16 degree
• Width: 36 Millimeter
• Device Size Text, specify: 0
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Height: 18 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375026716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142589

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, 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: 2017-04-26

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• 00191375026914: Interbody Fusion Device 20 Degree Standard 20mm
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• 00191375026884: Interbody Fusion Device 20 Degree Standard 17mm
• 00191375026877: Interbody Fusion Device 20 Degree Standard 16mm
• 00191375026860: Interbody Fusion Device 20 Degree Standard 15mm
• 00191375026853: Interbody Fusion Device 20 Degree Standard 14mm
• 00191375026846: Interbody Fusion Device 20 Degree Standard 13mm
• 00191375026839: Interbody Fusion Device 20 Degree Standard 12mm
• 00191375026822: Interbody Fusion Device 16 Degree X-Large 20mm
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• 00191375026761: Interbody Fusion Device 16 Degree X-Large 14mm