Endoskeleton TAS 2312-0116-S

GUDID M68223120116S0

Interbody Fusion Device 12 Degree Standard 16mm

TITAN SPINE, LLC

Metallic spinal interbody fusion cage

• Primary Device ID: M68223120116S0
• NIH Device Record Key: 788464cd-6349-4897-80b9-374ce8bfa003
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endoskeleton TAS
• Version Model Number: 2312-0116-S
• Catalog Number: 2312-0116-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
• 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: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree
• Height: 16 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 12 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M68223120116S0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111626

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: 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 TAS]

• M682230075250: Interbody Fusion Device 6.5mm Implant Bone Screw 25mm
• M682230065300: Interbody Fusion Device 6.5mm Implant Bone Screw 30mm
• M682230065200: Interbody Fusion Device 6.5mm Implant Bone Screw 20mm
• M682230055300: Interbody Fusion Device 5.5mm Implant Bone Screw 30mm
• M682230055250: Interbody Fusion Device 5.5mm Implant Bone Screw 25mm
• M682230055200: Interbody Fusion Device 5.5mm Implant Bone Screw 20mm
• M682230013020: HEX, SWIVEL, SCREWDRIVER
• M682230013010: HEX, STRAIGHT, SCREWDRIVER
• M682230011020: REVERSE THREAD EXTRACTOR
• M682230010340: HEX, U-JOINT SCREWDRIVER
• M682230010150: LOCKING, IMPLANT REMOVER
• M682230010120: IMPLANT REMOVER
• M68223121117S0: Interbody Fusion Device 12 Degree Hybrid 17mm
• M68223121117N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Hybrid 17mm
• M68223121116S0: Interbody Fusion Device 12 Degree Hybrid 16mm
• M68223121116N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Hybrid 16mm
• M68223121115S0: Interbody Fusion Device 12 Degree Hybrid 15mm
• M68223121115N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Hybrid 15mm
• M68223121114S0: Interbody Fusion Device 12 Degree Hybrid 14mm
• M68223121114N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Hybrid 14mm
• M68223121113S0: Interbody Fusion Device 12 Degree Hybrid 13mm
• M68223121113N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Hybrid 13mm
• M68223121112S0: Interbody Fusion Device 12 Degree Hybrid 12mm
• M68223121112N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Hybrid 12mm
• M68223121111S0: Interbody Fusion Device 12 Degree Hybrid 11mm
• M68223121111N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Hybrid 11mm
• M68223121110S0: Interbody Fusion Device 12 Degree Hybrid 10mm
• M68223121110N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Hybrid 10mm
• M68223120317S0: Interbody Fusion Device 12 Degree X-Large 17mm
• M68223120317N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree X-Large 17mm
• M68223120316S0: Interbody Fusion Device 12 Degree X-Large 16mm
• M68223120316N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree X-Large 16mm
• M68223120315S0: Interbody Fusion Device 12 Degree X-Large 15mm
• M68223120315N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree X-Large 15mm
• M68223120314S0: Interbody Fusion Device 12 Degree X-Large 14mm
• M68223120314N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree X-Large 14mm
• M68223120313S0: Interbody Fusion Device 12 Degree X-Large 13mm
• M68223120313N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree X-Large 13mm
• M68223120312S0: Interbody Fusion Device 12 Degree X-Large 12mm
• M68223120312N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree X-Large 12mm
• M68223120311S0: Interbody Fusion Device 12 Degree X-Large 11mm
• M68223120311N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree X-Large 11mm
• M68223120310S0: Interbody Fusion Device 12 Degree X-Large 10mm
• M68223120310N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree X-Large 10mm
• M68223120217S0: Interbody Fusion Device 12 Degree Large 17mm
• M68223120217N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Large 17mm
• M68223120216S0: Interbody Fusion Device 12 Degree Large 16mm
• M68223120216N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Large 16mm
• M68223120215S0: Interbody Fusion Device 12 Degree Large 15mm
• M68223120215N0: Interbody Fusion Device nanoLOCK Surface Technology 12 Degree Large 15mm