Vu a POD Prime NanoMetalene 35-57-1825

GUDID 10889981159603

Prime NM Implant, 35x27mm x 18mm, 25 Deg

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis

• Primary Device ID: 10889981159603
• NIH Device Record Key: a89c4397-eb0c-4a1f-85f6-e4451c27107c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vu a POD Prime NanoMetalene
• Version Model Number: 35-57-1825
• Catalog Number: 35-57-1825
• 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: true
• 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

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981159603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162351

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-06-12

On-Brand Devices [Vu a POD Prime NanoMetalene]

• 10889981160128: Prime NM Implant, 43x30mm x 18mm, 25 Deg
• 10889981159665: Prime NM Implant, 43x30mm x 16mm, 25 Deg
• 10889981159658: Prime NM Implant, 39x30mm x 18mm, 25 Deg
• 10889981159641: Prime NM Implant, 39x30mm x 16mm, 25 Deg
• 10889981159634: Prime NM Implant, 39x27mm x 18mm, 25 Deg
• 10889981159627: Prime NM Implant, 39x27mm x 16mm, 25 Deg
• 10889981159610: Prime NM Implant, 39x27mm x 14mm, 25 Deg
• 10889981159603: Prime NM Implant, 35x27mm x 18mm, 25 Deg
• 10889981159597: Prime NM Implant, 35x27mm x 16mm, 25 Deg
• 10889981159580: Prime NM Implant, 35x27mm x 14mm, 25 Deg
• 10889981159573: Prime NM Implant, 31x24mm x 18mm, 25 Deg
• 10889981159566: Prime NM Implant, 31x24mm x 16mm, 25 Deg
• 10889981159559: Prime NM Implant, 31x24mm x 14mm, 25 Deg