Pacifica™ 33-2614

GUDID 10889981031619

Pacifica Implant 9mm x 24mm x 14mm

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis

• Primary Device ID: 10889981031619
• NIH Device Record Key: 2232edce-f859-40f3-86bf-3a7b1882a5eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pacifica™
• Version Model Number: 33-2614
• Catalog Number: 33-2614
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	10889981031619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082310

FDA Product Code

• MQP: Spinal vertebral body replacement device

Sterilization

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

[10889981031619]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-07-26

On-Brand Devices [Pacifica™]

• 10889981062651: Pacifica Implant
• 10889981062644: Pacifica Hybrid Implant
• 10889981031619: Pacifica Implant 9mm x 24mm x 14mm