ENDOSKELETON® TA nanoLOCK® Surface Technology 2107-0317-N

GUDID 00191375012276

Interbody Fusion Device 7 Degree X-Large 17mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00191375012276
• NIH Device Record Key: f6a45674-b2af-4615-97d4-2c520b67284e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TA nanoLOCK® Surface Technology
• Version Model Number: 2107-0317-N
• Catalog Number: 2107-0317-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(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Height: 17 Millimeter
• Height: 17 Millimeter
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter
• Width: 40 Millimeter
• Depth: 27 Millimeter
• Angle: 7 degree
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Height: 17 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375012276 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080615
• Premarket Notification: K141953

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

On-Brand Devices [ENDOSKELETON® TA nanoLOCK® Surface Technology]

• 00191375012276: Interbody Fusion Device 7 Degree X-Large 17mm
• 00191375012269: Interbody Fusion Device 7 Degree X-Large 16mm
• 00191375012252: Interbody Fusion Device 7 Degree X-Large 15mm
• 00191375012245: Interbody Fusion Device 7 Degree X-Large 14mm
• 00191375012238: Interbody Fusion Device 7 Degree X-Large 13mm
• 00191375012221: Interbody Fusion Device 7 Degree X-Large 12mm
• 00191375012214: Interbody Fusion Device 7 Degree X-Large 11mm
• 00191375012207: Interbody Fusion Device 7 Degree X-Large 10mm
• 00191375012191: Interbody Fusion Device 7 Degree Large 17mm
• 00191375012184: Interbody Fusion Device 7 Degree Large 16mm
• 00191375012177: Interbody Fusion Device 7 Degree Large 15mm
• 00191375012160: Interbody Fusion Device 7 Degree Large 14mm
• 00191375012153: Interbody Fusion Device 7 Degree Large 13mm
• 00191375012146: Interbody Fusion Device 7 Degree Large 12mm
• 00191375012139: Interbody Fusion Device 7 Degree Large 11mm
• 00191375012122: Interbody Fusion Device 7 Degree Large 10mm
• 00191375012115: Interbody Fusion Device 7 Degree Standard 17mm
• 00191375012108: Interbody Fusion Device 7 Degree Standard 16mm
• 00191375012092: Interbody Fusion Device 7 Degree Standard 15mm
• 00191375012085: Interbody Fusion Device 7 Degree Standard 14mm
• 00191375012078: Interbody Fusion Device 7 Degree Standard 13mm
• 00191375012061: Interbody Fusion Device 7 Degree Standard 12mm
• 00191375012054: Interbody Fusion Device 7 Degree Standard 11mm
• 00191375012047: Interbody Fusion Device 7 Degree Standard 10mm