ENDOSKELETON TA VBR 2156-9120

GUDID M682215691200

7 DEG LORDOTIC, TRIAL, STANDARD, 20MM

TITAN SPINE, LLC

Spinal implant trial

• Primary Device ID: M682215691200
• NIH Device Record Key: cdf226b7-f9e2-403e-b744-ebb80983c2db
• Commercial Distribution Discontinuation: 2020-09-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ENDOSKELETON TA VBR
• Version Model Number: 2156-9120
• Catalog Number: 2156-9120
• 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: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree
• Height: 20 Millimeter
• Device Size Text, specify: 0
• Depth: 21 Millimeter
• Device Size Text, specify: 0
• Width: 32 Millimeter
• Angle: 7 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M682215691200 [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

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

Moist Heat or Steam Sterilization

[M682215691200]

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