ENDOSKELETON® TO nanoLOCK® Surface Technology 3114-3108-N

GUDID 00191375013662

Interbody Fusion Device 4 Degree Oblique 8mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00191375013662
• NIH Device Record Key: 8da53212-d867-443b-9e37-6c6e4a6834c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TO nanoLOCK® Surface Technology
• Version Model Number: 3114-3108-N
• Catalog Number: 3114-3108-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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0
• Depth: 11 Millimeter
• Device Size Text, specify: 0
• Angle: 4 degree
• Width: 31 Millimeter
• Height: 8 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375013662 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102067

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

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• 00191375013723: Interbody Fusion Device 4 Degree Oblique 14mm
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• 00191375013709: Interbody Fusion Device 4 Degree Oblique 12mm
• 00191375013693: Interbody Fusion Device 4 Degree Oblique 11mm
• 00191375013686: Interbody Fusion Device 4 Degree Oblique 10mm
• 00191375013679: Interbody Fusion Device 4 Degree Oblique 9mm
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• 00191375013655: Interbody Fusion Device 4 Degree PLIF 16mm
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• 00191375013631: Interbody Fusion Device 4 Degree PLIF 14mm
• 00191375013624: Interbody Fusion Device 4 Degree PLIF 13mm
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• 00191375013600: Interbody Fusion Device 4 Degree PLIF 11mm
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• 00191375013570: Interbody Fusion Device 4 Degree PLIF 8mm
• 00191375013563: Interbody Fusion Device 4 Degree PLIF 16mm
• 00191375013556: Interbody Fusion Device 4 Degree PLIF 15mm
• 00191375013549: Interbody Fusion Device 4 Degree PLIF 14mm
• 00191375013532: Interbody Fusion Device 4 Degree PLIF 13mm
• 00191375013525: Interbody Fusion Device 4 Degree PLIF 12mm
• 00191375013518: Interbody Fusion Device 4 Degree PLIF 11mm
• 00191375013501: Interbody Fusion Device 4 Degree PLIF 10mm
• 00191375013495: Interbody Fusion Device 4 Degree PLIF 9mm
• 00191375013488: Interbody Fusion Device 4 Degree PLIF 8mm
• 00191375013471: Interbody Fusion Device 0 Degree Convex Oblique 16mm
• 00191375013464: Interbody Fusion Device 0 Degree Convex Oblique 15mm
• 00191375013457: Interbody Fusion Device 0 Degree Convex Oblique 14mm
• 00191375013440: Interbody Fusion Device 0 Degree Convex Oblique 13mm
• 00191375013433: Interbody Fusion Device 0 Degree Convex Oblique 12mm
• 00191375013426: Interbody Fusion Device 0 Degree Convex Oblique 11mm
• 00191375013419: Interbody Fusion Device 0 Degree Convex Oblique 10mm
• 00191375013402: Interbody Fusion Device 0 Degree Convex Oblique 9mm
• 00191375013396: Interbody Fusion Device 0 Degree Convex Oblique 8mm
• 00191375013389: Interbody Fusion Device 0 Degree Convex PLIF 16mm
• 00191375013372: Interbody Fusion Device 0 Degree Convex PLIF 15mm
• 00191375013365: Interbody Fusion Device 0 Degree Convex PLIF 14mm
• 00191375013358: Interbody Fusion Device 0 Degree Convex PLIF 13mm
• 00191375013341: Interbody Fusion Device 0 Degree Convex PLIF 12mm
• 00191375013334: Interbody Fusion Device 0 Degree Convex PLIF 11mm
• 00191375013327: Interbody Fusion Device 0 Degree Convex PLIF 10mm
• 00191375013310: Interbody Fusion Device 0 Degree Convex PLIF 9mm
• 00191375013303: Interbody Fusion Device 0 Degree Convex PLIF 8mm
• 00191375013297: Interbody Fusion Device 0 Degree Convex PLIF 16mm
• 00191375013280: Interbody Fusion Device 0 Degree Convex PLIF 15mm
• 00191375013273: Interbody Fusion Device 0 Degree Convex PLIF 14mm
• 00191375013266: Interbody Fusion Device 0 Degree Convex PLIF 13mm
• 00191375013259: Interbody Fusion Device 0 Degree Convex PLIF 12mm