Vu ePOD™ 14-TA-2614

GUDID 10889981037109

14mm x 26mm Tapered 5 deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981037109
• NIH Device Record Key: ba363de1-0393-4e14-b00f-0a8711ce31c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vu ePOD™
• Version Model Number: 14-TA-2614
• Catalog Number: 14-TA-2614
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Device Count: 1
• DM Exempt: false
• 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: false
• 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(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981037109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071031

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10889981037109]

Moist Heat or Steam Sterilization

[10889981037109]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [Vu ePOD™]

• 10889981049201: Tapered Rectangular Spacer 30mm x 14.65mm
• 10889981049195: Tapered Rectangular Spacer 30mm x 13.33mm
• 10889981049188: Tapered Rectangular Spacer 30mm x 11.85mm
• 10889981049171: Tapered Rectangular Spacer 30mm x 10.5mm
• 10889981049164: Tapered Rectangular Spacer 30mm x 14.65mm
• 10889981049157: Tapered Rectangular Spacer 30mm x 13.33mm
• 10889981049140: Tapered Rectangular Spacer 30mm x 11.85mm
• 10889981049133: Tapered Rectangular Spacer 30mm x 10.5mm
• 10889981049126: Tapered Rectangular Spacer 26mm x 11.85mm
• 10889981049119: Tapered Rectangular Spacer 26mm x 10.5mm
• 10889981049102: Tapered Rectangular Spacer 26mm x 11.85mm
• 10889981049096: Tapered Rectangular Spacer 26mm x 10.5mm
• 10889981049089: Tapered Rectangular Spacer 22mm x 11.85mm
• 10889981049072: Tapered Rectangular Spacer 22mm x 10.5mm
• 10889981049065: Tapered Rectangular Spacer 22mm x 11.85mm
• 10889981049058: Tapered Rectangular Spacer 22mm x 10.5mm
• 10889981049041: Tapered Rectangular Spacer 18mm x 11.85mm
• 10889981049034: Tapered Rectangular Spacer 18mm x 10.5mm
• 10889981049027: Tapered Rectangular Spacer 18mm x 11.85mm
• 10889981049010: Tapered Rectangular Spacer 18mm x 10.5mm
• 10889981049003: 26mm Trial, 10 Deg, 16 mm
• 10889981048990: 26mm Trial, 10 Deg, 15 mm
• 10889981048983: 26mm Trial, 10 Deg, 14 mm
• 10889981048976: 26mm Trial, 10 Deg, 13 mm
• 10889981048969: 26mm Trial, 10 Deg, 12 mm
• 10889981048952: 26mm Trial, 10 Deg, 11 mm
• 10889981048945: 26mm Trial, 10 Deg, 10 mm
• 10889981048938: 22mm Trial, 10 Deg, 16 mm
• 10889981048921: 22mm Trial, 10 Deg, 15 mm
• 10889981048914: 22mm Trial, 10 Deg, 14 mm
• 10889981048907: 22mm Trial, 10 Deg, 13 mm
• 10889981048891: 22mm Trial, 10 Deg, 12 mm
• 10889981048884: 22mm Trial, 10 Deg, 11 mm
• 10889981048877: 22mm Trial, 10 Deg, 10 mm
• 10889981048860: 26mm Trial, 5 Deg, 16 mm
• 10889981048853: 26mm Trial, 5 Deg, 15 mm
• 10889981048846: 26mm Trial, 5 Deg, 14 mm
• 10889981048839: 26mm Trial, 5 Deg, 13 mm
• 10889981048822: 26mm Trial, 5 Deg, 12 mm
• 10889981048815: 26mm Trial, 5 Deg, 11 mm
• 10889981048808: 26mm Trial, 5 Deg, 10 mm
• 10889981048792: 26mm Trial, 5 Deg, 9 mm
• 10889981048785: 26mm Trial, 5 Deg, 8 mm
• 10889981048778: 22mm Trial, 5 Deg, 16 mm
• 10889981048761: 22mm Trial, 5 Deg, 15 mm
• 10889981048754: 22mm Trial, 5 Deg, 14 mm
• 10889981048747: 22mm Trial, 5 Deg, 13 mm
• 10889981048730: 22mm Trial, 5 Deg, 12 mm
• 10889981048723: 22mm Trial, 5 Deg, 11 mm
• 10889981048716: 22mm Trial, 5 Deg, 10 mm