Ventura NanoMetalene System 93-3755

GUDID 10889981152093

Ventura NM Trial, 9mm x 28mm x 16mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Spinal implant trial

• Primary Device ID: 10889981152093
• NIH Device Record Key: dbd488d3-12df-45a8-b16b-6b462507a341
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ventura NanoMetalene System
• Version Model Number: 93-3755
• Catalog Number: 93-3755
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981152093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173022

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981152093]

Moist Heat or Steam Sterilization

[10889981152093]

Moist Heat or Steam Sterilization

[10889981152093]

Moist Heat or Steam Sterilization

[10889981152093]

Moist Heat or Steam Sterilization

[10889981152093]

Moist Heat or Steam Sterilization

[10889981152093]

Moist Heat or Steam Sterilization

[10889981152093]

Moist Heat or Steam Sterilization

[10889981152093]

Moist Heat or Steam Sterilization

[10889981152093]

Moist Heat or Steam Sterilization

[10889981152093]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2017-11-17

On-Brand Devices [Ventura NanoMetalene System]

• 10889981152291: Ventura NM Trial, 11mm x 32mm x 17mm, Lordotic
• 10889981152284: Ventura NM Trial, 11mm x 32mm x 16mm, Lordotic
• 10889981152277: Ventura NM Trial, 11mm x 32mm x 15mm, Lordotic
• 10889981152260: Ventura NM Trial, 11mm x 32mm x 14mm, Lordotic
• 10889981152253: Ventura NM Trial, 11mm x 32mm x 13mm, Lordotic
• 10889981152246: Ventura NM Trial, 11mm x 32mm x 12mm, Lordotic
• 10889981152239: Ventura NM Trial, 11mm x 32mm x 11mm, Lordotic
• 10889981152222: Ventura NM Trial, 11mm x 32mm x 10mm, Lordotic
• 10889981152215: Ventura NM Trial, 11mm x 32mm x 09mm, Lordotic
• 10889981152208: Ventura NM Trial, 11mm x 28mm x 17mm, Lordotic
• 10889981152192: Ventura NM Trial, 11mm x 28mm x 16mm, Lordotic
• 10889981152185: Ventura NM Trial, 11mm x 28mm x 15mm, Lordotic
• 10889981152178: Ventura NM Trial, 11mm x 28mm x 14mm, Lordotic
• 10889981152161: Ventura NM Trial, 11mm x 28mm x 13mm, Lordotic
• 10889981152154: Ventura NM Trial, 11mm x 28mm x 12mm, Lordotic
• 10889981152147: Ventura NM Trial, 11mm x 28mm x 11mm, Lordotic
• 10889981152130: Ventura NM Trial, 11mm x 28mm x 10mm, Lordotic
• 10889981152123: Ventura NM Trial, 11mm x 28mm x 09mm, Lordotic
• 10889981152116: Ventura NM Trial, 11mm x 28mm x 08mm, Lordotic
• 10889981152109: Ventura NM Trial, 9mm x 28mm x 17mm, Lordotic
• 10889981152093: Ventura NM Trial, 9mm x 28mm x 16mm, Lordotic
• 10889981152086: Ventura NM Trial, 9mm x 28mm x 15mm, Lordotic
• 10889981152079: Ventura NM Trial, 9mm x 28mm x 14mm, Lordotic
• 10889981152062: Ventura NM Trial, 9mm x 28mm x 13mm, Lordotic
• 10889981152055: Ventura NM Trial, 9mm x 28mm x 12mm, Lordotic
• 10889981152048: Ventura NM Trial, 9mm x 28mm x 11mm, Lordotic
• 10889981152031: Ventura NM Trial, 9mm x 28mm x 10mm, Lordotic
• 10889981152024: Ventura NM Trial, 9mm x 28mm x 9mm, Lordotic
• 10889981152017: Ventura NM Trial, 9mm x 28mm x 8mm, Lordotic
• 10889981152000: Ventura NM Trial, 11mm x 24mm x 17mm, Lordotic
• 10889981151997: Ventura NM Trial, 11mm x 24mm x 16mm, Lordotic
• 10889981151980: Ventura NM Trial, 11mm x 24mm x 15mm, Lordotic
• 10889981151973: Ventura NM Trial, 11mm x 24mm x 14mm, Lordotic
• 10889981151966: Ventura NM Trial, 11mm x 24mm x 13mm, Lordotic
• 10889981151959: Ventura NM Trial, 11mm x 24mm x 12mm, Lordotic
• 10889981151942: Ventura NM Trial, 11mm x 24mm x 11mm, Lordotic
• 10889981151935: Ventura NM Trial, 11mm x 24mm x 10mm, Lordotic
• 10889981151928: Ventura NM Trial, 11mm x 24mm x 09mm, Lordotic
• 10889981151911: Ventura NM Trial, 11mm x 24mm x 08mm, Lordotic
• 10889981151904: Ventura NM Trial, 9mm x 24mm x 17mm, Lordotic
• 10889981151898: Ventura NM Trial, 9mm x 24mm x 16mm, Lordotic
• 10889981151881: Ventura NM Trial, 9mm x 24mm x 15mm, Lordotic
• 10889981151874: Ventura NM Trial, 9mm x 24mm x 14mm, Lordotic
• 10889981151867: Ventura NM Trial, 9mm x 24mm x 13mm, Lordotic
• 10889981151850: Ventura NM Trial, 9mm x 24mm x 12mm, Lordotic
• 10889981151843: Ventura NM Trial, 9mm x 24mm x 11mm, Lordotic
• 10889981151836: Ventura NM Trial, 9mm x 24mm x 10mm, Lordotic
• 10889981151829: Ventura NM Trial, 9mm x 24mm x 9mm, Lordotic
• 10889981151812: Ventura NM Trial, 9mm x 24mm x 8mm, Lordotic
• 10889981151805: Ventura NM Trial, 11mm x 24mm x 17mm