Endoskeleton TCS 5366-1409-S

GUDID M68253661409S0

Interbody Fusion Device 6 Degree Medium 9mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M68253661409S0
• NIH Device Record Key: 9c8f0b4d-52e5-4d81-ae2f-6ee7fb7f9cd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton TCS
• Version Model Number: 5366-1409-S
• Catalog Number: 5366-1409-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(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
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Angle: 6 degree
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Depth: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68253661409S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142940

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-17

On-Brand Devices [Endoskeleton TCS]

• M682530238200: Interbody Fusion Device 3.8mm Implant Locking Bone Screw 20mm
• M682530238190: Interbody Fusion Device 3.8mm Implant Locking Bone Screw 19mm
• M682530238180: Interbody Fusion Device 3.8mm Implant Locking Bone Screw 18mm
• M682530238170: Interbody Fusion Device 3.8mm Implant Locking Bone Screw 17mm
• M682530238160: Interbody Fusion Device 3.8mm Implant Locking Bone Screw 16mm
• M682530238150: Interbody Fusion Device 3.8mm Implant Locking Bone Screw 15mm
• M682530238140: Interbody Fusion Device 3.8mm Implant Locking Bone Screw 14mm
• M682530238130: Interbody Fusion Device 3.8mm Implant Locking Bone Screw 13mm
• M682530235200: Interbody Fusion Device 3.5mm Implant Locking Bone Screw 20mm
• M682530235190: Interbody Fusion Device 3.5mm Implant Locking Bone Screw 19mm
• M682530235180: Interbody Fusion Device 3.5mm Implant Locking Bone Screw 18mm
• M682530235170: Interbody Fusion Device 3.5mm Implant Locking Bone Screw 17mm
• M682530235160: Interbody Fusion Device 3.5mm Implant Locking Bone Screw 16mm
• M682530235150: Interbody Fusion Device 3.5mm Implant Locking Bone Screw 15mm
• M682530235140: Interbody Fusion Device 3.5mm Implant Locking Bone Screw 14mm
• M682530235130: Interbody Fusion Device 3.5mm Implant Locking Bone Screw 13mm
• M682530138200: Interbody Fusion Device 3.8mm Implant Bone Screw 20mm
• M682530138190: Interbody Fusion Device 3.8mm Implant Bone Screw 19mm
• M682530138180: Interbody Fusion Device 3.8mm Implant Bone Screw 18mm
• M682530138170: Interbody Fusion Device 3.8mm Implant Bone Screw 17mm
• M682530138160: Interbody Fusion Device 3.8mm Implant Bone Screw 16mm
• M682530138150: Interbody Fusion Device 3.8mm Implant Bone Screw 15mm
• M682530138140: Interbody Fusion Device 3.8mm Implant Bone Screw 14mm
• M682530138130: Interbody Fusion Device 3.8mm Implant Bone Screw 13mm
• M682530135200: Interbody Fusion Device 3.5mm Implant Bone Screw 20mm
• M682530135190: Interbody Fusion Device 3.5mm Implant Bone Screw 19mm
• M682530135180: Interbody Fusion Device 3.5mm Implant Bone Screw 18mm
• M682530135170: Interbody Fusion Device 3.5mm Implant Bone Screw 17mm
• M682530135160: Interbody Fusion Device 3.5mm Implant Bone Screw 16mm
• M682530135150: Interbody Fusion Device 3.5mm Implant Bone Screw 15mm
• M682530135140: Interbody Fusion Device 3.5mm Implant Bone Screw 14mm
• M682530135130: Interbody Fusion Device 3.5mm Implant Bone Screw 13mm
• M682521010480: BONE SCREW EXTRACTOR
• M682521010240: NO 8 HEXALOBE, U-JOINT DRIVER
• M682521010210: INSERTER
• M682521010050: NO 8 HEXALOBE, SWIVEL DRIVER
• M682521010040: NO 8 HEXALOBE, STRAIGHT DRIVER
• M68253861612S0: Interbody Fusion Device 6 Degree Large 12mm
• M68253861612N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 12mm
• M68253861611S0: Interbody Fusion Device 6 Degree Large 11mm
• M68253861611N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 11mm
• M68253861610S0: Interbody Fusion Device 6 Degree Large 10mm
• M68253861610N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 10mm
• M68253861609S0: Interbody Fusion Device 6 Degree Large 9mm
• M68253861609N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 9mm
• M68253861608S0: Interbody Fusion Device 6 Degree Large 8mm
• M68253861608N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 8mm
• M68253861607S0: Interbody Fusion Device 6 Degree Large 7mm
• M68253861607N0: Interbody Fusion Device nanoLOCK Surface Technology 6 Degree Large 7mm
• M68253861606S0: Interbody Fusion Device 6 Degree Large 6mm