Vu CPOD™ 11-10-2408

GUDID 10889981051945

Implant Non-Tapered 12x14x8mm (Strut)

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981051945
• NIH Device Record Key: 584506a8-2bad-44b9-9b79-0c5487bdc3b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vu CPOD™
• Version Model Number: 11-10-2408
• Catalog Number: 11-10-2408
• 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	10889981051945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050058

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[10889981051945]

Moist Heat or Steam Sterilization

[10889981051945]

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 CPOD™]

• 10889981062477: Vu L-Pod™ Posterior IBF Trial Set
• 10889981062460: Vu e-Pod™ Posterior IBF Set
• 10889981062453: Vu e-Pod™ Trial Set
• 10889981062446: VucPod™ Cervical IBF (Non-Strut)
• 10889981062439: VucPod™ Cervical IBF (Non-Strut)
• 10889981052089: Implant Tapered 12x14x10mm (Strut)
• 10889981052072: Implant Tapered 12x14x9mm (Strut)
• 10889981052065: Implant Tapered 12x14x8mm (Strut)
• 10889981052058: Implant Tapered 12x14x7mm (Strut)
• 10889981052041: Implant Tapered 12x14x6mm (Strut)
• 10889981052034: Implant Tapered 12x14x5mm (Strut)
• 10889981052027: Implant Tapered 10x12x10mm (Strut)
• 10889981052010: Implant Tapered 10x12x9mm (Strut)
• 10889981052003: Implant Tapered 10x12x8mm (Strut)
• 10889981051990: Implant Tapered 10x12x7mm (Strut)
• 10889981051983: Implant Tapered 10x12x6mm (Strut)
• 10889981051976: Implant Tapered 10x12x5mm (Strut)
• 10889981051969: Implant Non-Tapered 12x14x10mm (Strut)
• 10889981051952: Implant Non-Tapered 12x14x9mm (Strut)
• 10889981051945: Implant Non-Tapered 12x14x8mm (Strut)
• 10889981051938: Implant Non-Tapered 12x14x7mm (Strut)
• 10889981051921: Implant Non-Tapered 12x14x6mm (Strut)
• 10889981051914: Implant Non-Tapered 12x14x5mm (Strut)
• 10889981051907: Implant Non-Tapered 10x12x10mm (Strut)
• 10889981051891: Implant Non-Tapered 10x12x9mm (Strut)
• 10889981051884: Implant Non-Tapered 10x12x8mm (Strut)
• 10889981051877: Implant Non-Tapered 10x12x7mm (Strut)
• 10889981051860: Implant Non-Tapered 10x12x6mm (Strut)
• 10889981051853: Implant Non-Tapered 10x12x5mm (Strut)
• 10889981040413: Implant Inserter
• 10889981040406: Trial Inserter
• 10889981040390: Trial Non-Tapered 14x16x12mm (Non-Strut)
• 10889981040383: Trial Non-Tapered 14x16x11mm (Non-Strut)
• 10889981040376: Trial Non-Tapered 14x16x10mm (Non-Strut)
• 10889981040369: Trial Non-Tapered 14x16x9mm (Non-Strut)
• 10889981040352: Trial Non-Tapered 14x16x8mm (Non-Strut)
• 10889981040345: Trial Non-Tapered 14x16x7mm (Non-Strut)
• 10889981040338: Trial Non-Tapered 14x16x6mm (Non-Strut)
• 10889981040321: Trial Non-Tapered 14x16x5mm (Non-Strut)
• 10889981040314: Trial Non-Tapered 12x14x12mm (Non-Strut)
• 10889981040307: Trial Non-Tapered 12x14x11mm (Non-Strut)
• 10889981040291: Trial Non-Tapered 12x14x10mm (Non-Strut)
• 10889981040284: Trial Non-Tapered 12x14x9mm (Non-Strut)
• 10889981040277: Trial Non-Tapered 12x14x8mm (Non-Strut)
• 10889981040260: Trial Non-Tapered 12x14x7mm (Non-Strut)
• 10889981040253: Trial Non-Tapered 12x14x6mm (Non-Strut)
• 10889981040246: Trial Non-Tapered 12x14x5mm (Non-Strut)
• 10889981040239: Trial Non-Tapered 10x12x12mm (Non-Strut)
• 10889981040222: Trial Non-Tapered 10x12x11mm (Non-Strut)
• 10889981040215: Trial Non-Tapered 10x12x10mm (Non-Strut)