ENDOSKELETON® TL Sterile Barrier System 7107-1214-S

GUDID 00191375023289

Interbody Fusion Device 7 Degree 45 (M/L) 22 (A/P) 14 mm

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: 00191375023289
• NIH Device Record Key: 2ad95a87-fe85-4a73-9c84-d7e31b5bf541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TL Sterile Barrier System
• Version Model Number: 7107-1214-S
• Catalog Number: 7107-1214-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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Angle: 7 degree
• Width: 22 Millimeter
• Length: 45 Millimeter
• Height: 14 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375023289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140055

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® TL Sterile Barrier System]

• 00191375025214: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 16 mm
• 00191375025207: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 16 mm
• 00191375025191: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 16 mm
• 00191375025184: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 16 mm
• 00191375025177: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 16 mm
• 00191375025160: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 15 mm
• 00191375025153: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 15 mm
• 00191375025146: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 15 mm
• 00191375025139: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 15 mm
• 00191375025122: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 15 mm
• 00191375025115: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 14 mm
• 00191375025108: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 14 mm
• 00191375025092: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 14 mm
• 00191375025085: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 14 mm
• 00191375025078: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 14 mm
• 00191375025061: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 13 mm
• 00191375025054: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 13 mm
• 00191375025047: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 13 mm
• 00191375025030: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 13 mm
• 00191375025023: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 13 mm
• 00191375025016: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 12 mm
• 00191375025009: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 12 mm
• 00191375024996: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 12 mm
• 00191375024989: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 12 mm
• 00191375024972: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 12 mm
• 00191375024965: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 11 mm
• 00191375024958: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 11 mm
• 00191375024941: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 11 mm
• 00191375024934: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 11 mm
• 00191375024927: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 11 mm
• 00191375024910: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 10 mm
• 00191375024903: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 10 mm
• 00191375024897: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 10 mm
• 00191375024880: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 10 mm
• 00191375024873: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 10 mm
• 00191375024866: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 9 mm
• 00191375024859: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 9 mm
• 00191375024842: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 9 mm
• 00191375024835: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 9 mm
• 00191375024828: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 9 mm
• 00191375024811: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 8 mm
• 00191375024804: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 8 mm
• 00191375024798: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 8 mm
• 00191375024781: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 8 mm
• 00191375024774: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 8 mm
• 00191375024767: Interbody Fusion Device 12 Degree 60 (M/L) 22 (A/P) 16 mm
• 00191375024750: Interbody Fusion Device 12 Degree 55 (M/L) 22 (A/P) 16 mm
• 00191375024743: Interbody Fusion Device 12 Degree 50 (M/L) 22 (A/P) 16 mm
• 00191375024736: Interbody Fusion Device 12 Degree 45 (M/L) 22 (A/P) 16 mm
• 00191375024729: Interbody Fusion Device 12 Degree 40 (M/L) 22 (A/P) 16 mm