SeaSpine Spacer System - Ventura™ NanoMetalene® 33-6809

GUDID 10889981049911

Ventura NM Implant, 9mm x 28mm x 9mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981049911
• NIH Device Record Key: 21905b20-2656-4670-a2e0-c75fb15b5eeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine Spacer System - Ventura™ NanoMetalene®
• Version Model Number: 33-6809
• Catalog Number: 33-6809
• 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
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• 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	10889981049911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142488

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, cervical

Sterilization

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

[10889981049911]

Moist Heat or Steam Sterilization

[10889981049911]

Moist Heat or Steam Sterilization

[10889981049911]

Moist Heat or Steam Sterilization

[10889981049911]

Moist Heat or Steam Sterilization

[10889981049911]

Moist Heat or Steam Sterilization

[10889981049911]

Moist Heat or Steam Sterilization

[10889981049911]

Moist Heat or Steam Sterilization

[10889981049911]

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 [SeaSpine Spacer System - Ventura™ NanoMetalene®]

• 10889981050696: Ventura NM Instrument Tray
• 10889981050689: Ventura NM Trial, 11mm x 32mm x 18mm
• 10889981050672: Ventura NM Trial, 11mm x 32mm x 17mm
• 10889981050665: Ventura NM Trial, 11mm x 32mm x 16mm
• 10889981050658: Ventura NM Trial, 11mm x 32mm x 15mm
• 10889981050641: Ventura NM Trial, 11mm x 32mm x 14mm
• 10889981050634: Ventura NM Trial, 11mm x 32mm x 13mm
• 10889981050627: Ventura NM Trial, 11mm x 32mm x 12mm
• 10889981050610: Ventura NM Trial, 11mm x 32mm x 11mm
• 10889981050603: Ventura NM Trial, 11mm x 32mm x 10mm
• 10889981050597: Ventura NM Trial, 11mm x 32mm x 9mm
• 10889981050580: Ventura NM Trial, 11mm x 32mm x 8mm
• 10889981050573: Ventura NM Trial, 11mm x 32mm x 7mm
• 10889981050566: Ventura NM Trial, 9mm x 32mm x 18mm
• 10889981050559: Ventura NM Trial, 9mm x 32mm x 17mm
• 10889981050542: Ventura NM Trial, 9mm x 32mm x 16mm
• 10889981050535: Ventura NM Trial, 9mm x 32mm x 15mm
• 10889981050528: Ventura NM Trial, 9mm x 32mm x 14mm
• 10889981050511: Ventura NM Trial, 9mm x 32mm x 13mm
• 10889981050504: Ventura NM Trial, 9mm x 32mm x 12mm
• 10889981050498: Ventura NM Trial, 9mm x 32mm x 11mm
• 10889981050481: Ventura NM Trial, 9mm x 32mm x 10mm
• 10889981050474: Ventura NM Trial, 9mm x 32mm x 9mm
• 10889981050467: Ventura NM Trial, 9mm x 32mm x 8mm
• 10889981050450: Ventura NM Trial, 9mm x 32mm x 7mm
• 10889981050443: Ventura NM Trial, 11mm x 28mm x 18mm
• 10889981050436: Ventura NM Trial, 11mm x 28mm x 17mm
• 10889981050429: Ventura NM Trial, 11mm x 28mm x 16mm
• 10889981050412: Ventura NM Trial, 11mm x 28mm x 15mm
• 10889981050405: Ventura NM Trial, 11mm x 28mm x 14mm
• 10889981050399: Ventura NM Trial, 11mm x 28mm x 13mm
• 10889981050382: Ventura NM Trial, 11mm x 28mm x 12mm
• 10889981050375: Ventura NM Trial, 11mm x 28mm x 11mm
• 10889981050368: Ventura NM Trial, 11mm x 28mm x 10mm
• 10889981050351: Ventura NM Trial, 11mm x 28mm x 9mm
• 10889981050344: Ventura NM Trial, 11mm x 28mm x 8mm
• 10889981050337: Ventura NM Trial, 11mm x 28mm x 7mm
• 10889981050320: Ventura NM Trial, 9mm x 28mm x 18mm
• 10889981050313: Ventura NM Trial, 9mm x 28mm x 17mm
• 10889981050306: Ventura NM Trial, 9mm x 28mm x 16mm
• 10889981050290: Ventura NM Trial, 9mm x 28mm x 15mm
• 10889981050283: Ventura NM Trial, 9mm x 28mm x 14mm
• 10889981050276: Ventura NM Trial, 9mm x 28mm x 13mm
• 10889981050269: Ventura NM Trial, 9mm x 28mm x 12mm
• 10889981050252: Ventura NM Trial, 9mm x 28mm x 11mm
• 10889981050245: Ventura NM Trial, 9mm x 28mm x 10mm
• 10889981050238: Ventura NM Trial, 9mm x 28mm x 9mm
• 10889981050221: Ventura NM Trial, 9mm x 28mm x 8mm
• 10889981050214: Ventura NM Trial, 9mm x 28mm x 7mm
• 10889981050207: Ventura NM Instrument Tray