ENDOSKELETON® TAS Hyperlordotic Sterile Barrier System 2324-0220-S

GUDID 00191375027201

Interbody Fusion Device 24 Degree Large 20mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00191375027201
• NIH Device Record Key: 1d27cef5-52ab-4173-bcc5-b1fada9421c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TAS Hyperlordotic Sterile Barrier System
• Version Model Number: 2324-0220-S
• Catalog Number: 2324-0220-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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Width: 36 Millimeter
• Depth: 24 Millimeter
• Device Size Text, specify: 0
• Angle: 24 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375027201 [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

On-Brand Devices [ENDOSKELETON® TAS Hyperlordotic Sterile Barrier System]

• 00191375027256: Interbody Fusion Device 24 Degree X-Large 20mm
• 00191375027249: Interbody Fusion Device 24 Degree X-Large 19mm
• 00191375027232: Interbody Fusion Device 24 Degree X-Large 18mm
• 00191375027225: Interbody Fusion Device 24 Degree X-Large 17mm
• 00191375027218: Interbody Fusion Device 24 Degree X-Large 16mm
• 00191375027201: Interbody Fusion Device 24 Degree Large 20mm
• 00191375027195: Interbody Fusion Device 24 Degree Large 19mm
• 00191375027188: Interbody Fusion Device 24 Degree Large 18mm
• 00191375027171: Interbody Fusion Device 24 Degree Large 17mm
• 00191375027164: Interbody Fusion Device 24 Degree Large 16mm
• 00191375027157: Interbody Fusion Device 24 Degree Large 15mm
• 00191375027140: Interbody Fusion Device 24 Degree Standard 20mm
• 00191375027133: Interbody Fusion Device 24 Degree Standard 19mm
• 00191375027126: Interbody Fusion Device 24 Degree Standard 18mm
• 00191375027119: Interbody Fusion Device 24 Degree Standard 17mm
• 00191375027102: Interbody Fusion Device 24 Degree Standard 16mm
• 00191375027096: Interbody Fusion Device 24 Degree Standard 15mm
• 00191375027089: Interbody Fusion Device 24 Degree Standard 14mm
• 00191375027072: Interbody Fusion Device 24 Degree Standard 13mm
• 00191375027065: Interbody Fusion Device 20 Degree X-Large 20mm
• 00191375027058: Interbody Fusion Device 20 Degree X-Large 19mm
• 00191375027041: Interbody Fusion Device 20 Degree X-Large 18mm
• 00191375027034: Interbody Fusion Device 20 Degree X-Large 17mm
• 00191375027027: Interbody Fusion Device 20 Degree X-Large 16mm
• 00191375027010: Interbody Fusion Device 20 Degree X-Large 15mm
• 00191375027003: Interbody Fusion Device 20 Degree X-Large 14mm
• 00191375026990: Interbody Fusion Device 20 Degree Large 20mm
• 00191375026983: Interbody Fusion Device 20 Degree Large 19mm
• 00191375026976: Interbody Fusion Device 20 Degree Large 18mm
• 00191375026969: Interbody Fusion Device 20 Degree Large 17mm
• 00191375026952: Interbody Fusion Device 20 Degree Large 16mm
• 00191375026945: Interbody Fusion Device 20 Degree Large 15mm
• 00191375026938: Interbody Fusion Device 20 Degree Large 14mm
• 00191375026921: Interbody Fusion Device 20 Degree Large 13mm
• 00191375026914: Interbody Fusion Device 20 Degree Standard 20mm
• 00191375026907: Interbody Fusion Device 20 Degree Standard 19mm
• 00191375026891: Interbody Fusion Device 20 Degree Standard 18mm
• 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
• 00191375026815: Interbody Fusion Device 16 Degree X-Large 19mm
• 00191375026808: Interbody Fusion Device 16 Degree X-Large 18mm
• 00191375026792: Interbody Fusion Device 16 Degree X-Large 17mm
• 00191375026785: Interbody Fusion Device 16 Degree X-Large 16mm
• 00191375026778: Interbody Fusion Device 16 Degree X-Large 15mm
• 00191375026761: Interbody Fusion Device 16 Degree X-Large 14mm