ENDOSKELETON® TCS 5366-1410

GUDID 00191375010982

Interbody Fusion Device 6 Degree Medium 10mm

TITAN SPINE, LLC

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Primary Device ID	00191375010982
NIH Device Record Key	c69c930a-47c0-47c3-8d18-80165d095000
Commercial Distribution Status	In Commercial Distribution
Brand Name	ENDOSKELETON® TCS
Version Model Number	5366-1410
Catalog Number	5366-1410
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	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(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	10 Millimeter
Height	10 Millimeter
Height	10 Millimeter
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00191375010982 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K142940

FDA Product Code

OVE	Intervertebral fusion device with integrated fixation, cervical