ENDOSKELETON® 11-01486-00

GUDID 00191375038788

Inner Tray Lid

TITAN SPINE, LLC

Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable Instrument tray, reusable

• Primary Device ID: 00191375038788
• NIH Device Record Key: 25223d96-ce4b-480c-b948-241cac5b7a27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOSKELETON®
• Version Model Number: 11-01486-00
• Catalog Number: 11-01486-00
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch
• Device Size Text, specify: 0
• Width: 10 Inch
• Length: 21 Inch
• Height: 1 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375038788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111626

FDA Product Code

• LRP: TRAY, SURGICAL
• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

[00191375038788]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-11
• Device Publish Date: 2019-11-01

On-Brand Devices [ENDOSKELETON®]

• 00191375027768: Hudson Connect, T-Handle Parallel Q.C. Flats
• 00191375025818: Hudson Connect, T-Handle
• 00191375050841: Perforated Tray Lid
• 00191375038788: Inner Tray Lid
• 00191375051763: Perforated, Lower, Inner Tray
• 00191375051756: Perforated, Upper, Inner Tray
• 00191375051749: Perforated, Tray, Base
• 00191375051480: Tray Base 5"
• 00191375051428: Inner Tray, Top
• 00191375051411: Inner Tray, Middle
• 00191375051398: Modified JK488 Generic Tray Lid
• 00191375051381: Modified JK442 Generic Tray Base
• 00191375051374: Modified JK440 GenericTray Base
• 00191375052579: Generic Lid
• M682420001130: Hudson Connect, T-Handle