ENDOSKELETON TA VBR 2156-9118

GUDID M682215691180

7 DEG LORDOTIC, TRIAL, STANDARD, 18MM

TITAN SPINE, LLC

Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial Spinal implant trial

• Primary Device ID: M682215691180
• NIH Device Record Key: 66161619-814a-4dc9-9de4-d7e97a3f6a41
• Commercial Distribution Discontinuation: 2020-09-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ENDOSKELETON TA VBR
• Version Model Number: 2156-9118
• Catalog Number: 2156-9118
• 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(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

• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 18 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Width: 32 Millimeter
• Angle: 7 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M682215691180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032812

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

[M682215691180]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-09-22
• Device Publish Date: 2016-09-17

On-Brand Devices [ENDOSKELETON TA VBR]

• M682220000010: IMPLANT CADDY
• M682215692200: 7 DEG LORDOTIC, TRIAL, LARGE, 20MM
• M682215692180: 7 DEG LORDOTIC, TRIAL, LARGE, 18MM
• M682215691200: 7 DEG LORDOTIC, TRIAL, STANDARD, 20MM
• M682215691180: 7 DEG LORDOTIC, TRIAL, STANDARD, 18MM
• M682215672200: 7 DEG LORDOTIC, RASP, LARGE, 20MM
• M682215672180: 7 DEG LORDOTIC, RASP, LARGE, 18MM
• M682215671200: 7 DEG LORDOTIC, RASP, STANDARD, 20MM
• M682215671180: 7 DEG LORDOTIC, RASP, STANDARD, 18MM