ENDOSKELETON® TAS Sterile Barrier System 2300-6535-S

GUDID 00191375029076

Bone Screw, 6.5mm x 35mm

TITAN SPINE, LLC

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 00191375029076
• NIH Device Record Key: 24323d5d-cd6f-43e7-a800-cad23931cf95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON® TAS Sterile Barrier System
• Version Model Number: 2300-6535-S
• Catalog Number: 2300-6535-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(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
• 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
• 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

• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
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• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Length: 35 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375029076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111626
• Premarket Notification: K173535

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-08
• Device Publish Date: 2019-09-30

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• 00191375021018: Interbody Fusion Device 12 Degree Large 10mm
• 00191375021001: Interbody Fusion Device 12 Degree Standard 17mm
• 00191375020998: Interbody Fusion Device 12 Degree Standard 16mm
• 00191375020981: Interbody Fusion Device 12 Degree Standard 15mm
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• 00191375020967: Interbody Fusion Device 12 Degree Standard 13mm
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• 00191375020943: Interbody Fusion Device 12 Degree Standard 11mm
• 00191375020936: Interbody Fusion Device 12 Degree Standard 10mm
• 00191375020929: Interbody Fusion Device 12 Degree Hybrid 17mm
• 00191375020912: Interbody Fusion Device 12 Degree Hybrid 16mm
• 00191375020905: Interbody Fusion Device 12 Degree Hybrid 15mm
• 00191375020899: Interbody Fusion Device 12 Degree Hybrid 14mm
• 00191375020882: Interbody Fusion Device 12 Degree Hybrid 13mm
• 00191375020875: Interbody Fusion Device 12 Degree Hybrid 12mm
• 00191375020868: Interbody Fusion Device 12 Degree Hybrid 11mm
• 00191375020851: Interbody Fusion Device 12 Degree Hybrid 10mm
• 00191375020844: Interbody Fusion Device 7 Degree X-Large 17mm
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• 00191375020820: Interbody Fusion Device 7 Degree X-Large 15mm
• 00191375020813: Interbody Fusion Device 7 Degree X-Large 14mm
• 00191375020806: Interbody Fusion Device 7 Degree X-Large 13mm
• 00191375020790: Interbody Fusion Device 7 Degree X-Large 12mm
• 00191375020783: Interbody Fusion Device 7 Degree X-Large 11mm
• 00191375020776: Interbody Fusion Device 7 Degree X-Large 10mm
• 00191375020769: Interbody Fusion Device 7 Degree Large 17mm
• 00191375020752: Interbody Fusion Device 7 Degree Large 16mm
• 00191375020745: Interbody Fusion Device 7 Degree Large 15mm
• 00191375020738: Interbody Fusion Device 7 Degree Large 14mm
• 00191375020721: Interbody Fusion Device 7 Degree Large 13mm
• 00191375020714: Interbody Fusion Device 7 Degree Large 12mm
• 00191375020707: Interbody Fusion Device 7 Degree Large 11mm
• 00191375020691: Interbody Fusion Device 7 Degree Large 10mm
• 00191375020684: Interbody Fusion Device 7 Degree Standard 17mm
• 00191375020677: Interbody Fusion Device 7 Degree Standard 16mm