ENDOSKELETON® TL nanoLOCK® Surface Technology 7112-0210-N

GUDID 00191375017127

Interbody Fusion Device 12 Degree 45 (M/L) 18 (A/P) 10 mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00191375017127
• NIH Device Record Key: 3e4db38d-1ad2-4972-9490-52369ca2e35e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TL nanoLOCK® Surface Technology
• Version Model Number: 7112-0210-N
• Catalog Number: 7112-0210-N
• 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

Device Dimensions

• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter
• Angle: 12 degree
• Device Size Text, specify: 0
• Width: 18 Millimeter
• Length: 45 Millimeter
• Device Size Text, specify: 0
• Height: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375017127 [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: 5
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-12-15

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• 00191375018346: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 16 mm
• 00191375018339: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 16 mm
• 00191375018322: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 16 mm
• 00191375018315: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 16 mm
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• 00191375018292: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 15 mm
• 00191375018285: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 15 mm
• 00191375018278: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 15 mm
• 00191375018261: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 15 mm
• 00191375018254: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 14 mm
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• 00191375018230: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 14 mm
• 00191375018223: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 14 mm
• 00191375018216: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 14 mm
• 00191375018209: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 13 mm
• 00191375018193: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 13 mm
• 00191375018186: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 13 mm
• 00191375018179: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 13 mm
• 00191375018162: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 13 mm
• 00191375018155: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 12 mm
• 00191375018148: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 12 mm
• 00191375018131: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 12 mm
• 00191375018124: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 12 mm
• 00191375018117: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 12 mm
• 00191375018100: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 11 mm
• 00191375018094: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 11 mm
• 00191375018087: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 11 mm
• 00191375018070: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 11 mm
• 00191375018063: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 11 mm
• 00191375018056: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 10 mm
• 00191375018049: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 10 mm
• 00191375018032: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 10 mm
• 00191375018025: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 10 mm
• 00191375018018: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 10 mm
• 00191375018001: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 9 mm
• 00191375017998: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 9 mm
• 00191375017981: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 9 mm
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• 00191375017967: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 9 mm
• 00191375017950: Interbody Fusion Device 12 Degree 60 (M/L) 26 (A/P) 8 mm
• 00191375017943: Interbody Fusion Device 12 Degree 55 (M/L) 26 (A/P) 8 mm
• 00191375017936: Interbody Fusion Device 12 Degree 50 (M/L) 26 (A/P) 8 mm
• 00191375017929: Interbody Fusion Device 12 Degree 45 (M/L) 26 (A/P) 8 mm
• 00191375017912: Interbody Fusion Device 12 Degree 40 (M/L) 26 (A/P) 8 mm
• 00191375017905: Interbody Fusion Device 12 Degree 60 (M/L) 22 (A/P) 16 mm
• 00191375017899: Interbody Fusion Device 12 Degree 55 (M/L) 22 (A/P) 16 mm
• 00191375017882: Interbody Fusion Device 12 Degree 50 (M/L) 22 (A/P) 16 mm
• 00191375017875: Interbody Fusion Device 12 Degree 45 (M/L) 22 (A/P) 16 mm
• 00191375017868: Interbody Fusion Device 12 Degree 40 (M/L) 22 (A/P) 16 mm