Vu cPOD 12-TA-2612

GUDID 10889981108564

Implant Tapered 26x12mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981108564
• NIH Device Record Key: 96c49f01-e425-42ed-8cd7-208b6e492f1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vu cPOD
• Version Model Number: 12-TA-2612
• Catalog Number: 12-TA-2612
• 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: true
• 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	10889981108564 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082712

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10889981108564]

Moist Heat or Steam Sterilization

[10889981108564]

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: 2015-09-26

On-Brand Devices [Vu cPOD]

• 10889981135287: Vu c-POD, 14x16 Implant Caddy
• 10889981135270: Vu c-POD, 12x14 Implant Caddy
• 10889981135263: Vu c-POD, 10x12 Implant Caddy
• 10889981135256: Vu c-POD, Sterilization Tray 2
• 10889981135249: Vu c-POD, Sterilization Tray 1
• 10889981135232: Vu c-POD, Sterilization Lid
• 10889981135225: Vu c-POD, Sterilization Case
• 10889981121112: Rasp 12mm Tapered
• 10889981108564: Implant Tapered 26x12mm
• 10889981108533: Implant Tapered 26x9mm
• 10889981108465: Implant Tapered 22x11mm
• 10889981106973: Case
• 10889981106966: Case
• 10889981106959: Rasp 11mm Tapered
• 10889981106942: Rasp 10mm Tapered
• 10889981106935: Rasp 9mm Tapered
• 10889981106928: Rasp 8mm Tapered
• 10889981106911: Rasp 7mm Tapered
• 10889981106904: Rasp 6mm Tapered
• 10889981106898: Rasp 5mm Tapered
• 10889981106881: Graft Tamp
• 10889981106874: Graft Packer Block
• 10889981106850: Graft Small Tamp Tool (Strut)
• 10889981106843: Graft Large Tamp Tool (Strut)