SeaSpine Spacer System - Ventura™ 93-3381

GUDID 10889981033361

13mm Long Ventura Trial

SEASPINE ORTHOPEDICS CORPORATION

Spinal implant trial

• Primary Device ID: 10889981033361
• NIH Device Record Key: 15aafc83-474c-4d93-b78e-d835a6bc6810
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine Spacer System - Ventura™
• Version Model Number: 93-3381
• Catalog Number: 93-3381
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Device Count: 1
• DM Exempt: true
• 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(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com
• Phone: +1(866)942-8698
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981033361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082310

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[10889981033361]

Moist Heat or Steam Sterilization

[10889981033361]

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: 2015-09-24

On-Brand Devices [SeaSpine Spacer System - Ventura™]

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• 10889981059026: Ventura Implant, 9mm x 28mm x 18mm
• 10889981059019: Ventura Implant, 9mm x 28mm x 17mm
• 10889981059002: Ventura Implant, 9mm x 28mm x 16mm
• 10889981058999: Ventura Implant, 9mm x 28mm x 15mm
• 10889981058982: Ventura Implant, 9mm x 28mm x 14mm
• 10889981058975: Ventura Implant, 9mm x 28mm x 13mm
• 10889981058968: Ventura Implant, 9mm x 28mm x 12mm
• 10889981058951: Ventura Implant, 9mm x 28mm x 11mm
• 10889981058944: Ventura Implant, 9mm x 28mm x 10mm
• 10889981058937: Ventura Implant, 9mm x 28mm x 9mm
• 10889981058920: Ventura Implant, 9mm x 28mm x 8mm
• 10889981058913: Ventura Implant, 9mm x 28mm x 7mm
• 10889981033644: Ventura Trial, 11mm x 28mm x 17mm
• 10889981033637: Ventura Trial, 11mm x 28mm x 16mm
• 10889981033620: Ventura Trial, 11mm x 28mm x 15mm
• 10889981033613: Ventura Trial, 11mm x 28mm x 14mm
• 10889981033606: Ventura Trial, 11mm x 28mm x 13mm
• 10889981033590: Ventura Trial, 11mm x 28mm x 12mm
• 10889981033583: Ventura Trial, 11mm x 28mm x 11mm
• 10889981033576: Ventura Trial, 11mm x 28mm x 10mm
• 10889981033569: Ventura Trial, 11mm x 28mm x 9mm
• 10889981033552: Ventura Trial, 11mm x 28mm x 8mm
• 10889981033545: Ventura Trial, 11mm x 28mm x 7mm
• 10889981033538: Fixed Ventura Trial, 9mm x 28mm x 18mm
• 10889981033521: Fixed Ventura Trial, 9mm x 28mm x 17mm
• 10889981033514: Fixed Ventura Trial, 9mm x 28mm x 16mm
• 10889981033507: Fixed Ventura Trial, 9mm x 28mm x 15mm
• 10889981033491: Fixed Ventura Trial, 9mm x 28mm x 14mm
• 10889981033484: Fixed Ventura Trial, 9mm x 28mm x 13mm
• 10889981033477: Fixed Ventura Trial, 9mm x 28mm x 12mm
• 10889981033460: Fixed Ventura Trial, 9mm x 28mm x 11mm
• 10889981033453: Fixed Ventura Trial, 9mm x 28mm x 10mm
• 10889981033446: Fixed Ventura Trial, 9mm x 28mm x 9mm
• 10889981033439: Fixed Ventura Trial, 9mm x 28mm x 8mm
• 10889981033422: Fixed Ventura Trial, 9mm x 28mm x 7mm
• 10889981033415: 18mm Long Ventura Trial
• 10889981033408: 17mm Long Ventura Trial
• 10889981033392: 16mm Long Ventura Trial
• 10889981033385: 15mm Long Ventura Trial
• 10889981033378: 14mm Long Ventura Trial
• 10889981033361: 13mm Long Ventura Trial
• 10889981033354: 12mm Long Ventura Trial
• 10889981033347: 11mm Long Ventura Trial
• 10889981033330: 10mm Long Ventura Trial
• 10889981033323: 9mm Long Ventura Trial
• 10889981033316: 8mm Long Ventura Trial
• 10889981033293: Ventura Trial, 9mm x 28mm x 17mm
• 10889981033279: Ventura Trial, 9mm x 28mm x 15mm