Endoskeleton TCS 5360-1409-S

GUDID M68253601409S0

Interbody Fusion Device Parallel Medium 9mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: M68253601409S0
• NIH Device Record Key: 31d65afa-17ca-4dce-88a0-a3ce83346405
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton TCS
• Version Model Number: 5360-1409-S
• Catalog Number: 5360-1409-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
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
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• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
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• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
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• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter
• Height: 9 Millimeter
• Device Size Text, specify: 0
• Depth: 14 Millimeter
• Device Size Text, specify: 0
• Width: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68253601409S0 [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