SeaSpine Spacer System - Pacifica™ 33-5208

GUDID 10889981031770

Pacifica Implant 9mm x 20mm x 8mm, Lordotic

SEASPINE ORTHOPEDICS CORPORATION

Vertebral body prosthesis, non-sterile

• Primary Device ID: 10889981031770
• NIH Device Record Key: 199eafe8-a2ed-46df-b8df-a236cb5b0c30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine Spacer System - Pacifica™
• Version Model Number: 33-5208
• Catalog Number: 33-5208
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981031770 [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

[10889981031770]

Moist Heat or Steam Sterilization

[10889981031770]

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 - Pacifica™]

• 10889981058906: Pacifica Trial, 9mm x 24mm x 18mm
• 10889981058890: Pacifica Trial, 9mm x 24mm x 17mm
• 10889981058883: Pacifica Trial, 9mm x 24mm x 16mm
• 10889981058876: Pacifica Trial, 9mm x 24mm x 15mm
• 10889981058869: Pacifica Trial, 9mm x 24mm x 14mm
• 10889981058852: Pacifica Trial, 9mm x 24mm x 13mm
• 10889981058845: Pacifica Trial, 9mm x 24mm x 12mm
• 10889981058838: Pacifica Trial, 9mm x 24mm x 11mm
• 10889981058821: Pacifica Trial, 9mm x 24mm x 10mm
• 10889981058814: Pacifica Trial, 9mm x 24mm x 9mm
• 10889981058807: Pacifica Trial, 9mm x 24mm x 8mm
• 10889981058791: Pacifica Trial, 9mm x 24mm x 7mm
• 10889981058784: Pacifica Trial, 9mm x 20mm x 18mm
• 10889981058777: Pacifica Trial, 9mm x 20mm x 17mm
• 10889981058760: Pacifica Trial, 9mm x 20mm x 16mm
• 10889981058753: Pacifica Trial, 9mm x 20mm x 15mm
• 10889981058746: Pacifica Trial, 9mm x 20mm x 14mm
• 10889981058739: Pacifica Trial, 9mm x 20mm x 13mm
• 10889981058722: Pacifica Trial, 9mm x 20mm x 12mm
• 10889981058715: Pacifica Trial, 9mm x 20mm x 11mm
• 10889981058708: Pacifica Trial, 9mm x 20mm x 10mm
• 10889981058692: Pacifica Trial, 9mm x 20mm x 9mm
• 10889981058685: Pacifica Trial, 9mm x 20mm x 8mm
• 10889981058678: Pacifica Trial, 9mm x 20mm x 7mm
• 10889981058661: Pacifica-S Implant, 9mm x 24mm x 18mm
• 10889981058654: Pacifica-S Implant, 9mm x 24mm x 17mm
• 10889981058647: Pacifica-S Implant, 9mm x 24mm x 16mm
• 10889981058630: Pacifica-S Implant, 9mm x 24mm x 15mm
• 10889981058623: Pacifica-S Implant, 9mm x 24mm x 14mm
• 10889981058616: Pacifica-S Implant, 9mm x 24mm x 13mm
• 10889981058609: Pacifica-S Implant, 9mm x 24mm x 12mm
• 10889981058593: Pacifica-S Implant, 9mm x 24mm x 11mm
• 10889981058586: Pacifica-S Implant, 9mm x 24mm x 10mm
• 10889981058579: Pacifica-S Implant, 9mm x 24mm x 9mm
• 10889981058562: Pacifica-S Implant, 9mm x 24mm x 8mm
• 10889981058555: Pacifica-S Implant, 9mm x 24mm x 7mm
• 10889981058548: Pacifica-S Implant, 9mm x 20mm x 18mm
• 10889981058531: Pacifica-S Implant, 9mm x 20mm x 17mm
• 10889981058524: Pacifica-S Implant, 9mm x 20mm x 16mm
• 10889981058517: Pacifica-S Implant, 9mm x 20mm x 15mm
• 10889981058500: Pacifica-S Implant, 9mm x 20mm x 14mm
• 10889981058494: Pacifica-S Implant, 9mm x 20mm x 13mm
• 10889981058487: Pacifica-S Implant, 9mm x 20mm x 12mm
• 10889981058470: Pacifica-S Implant, 9mm x 20mm x 11mm
• 10889981058463: Pacifica-S Implant, 9mm x 20mm x 10mm
• 10889981058456: Pacifica-S Implant, 9mm x 20mm x 9mm
• 10889981058449: Pacifica-S Implant, 9mm x 20mm x 8mm
• 10889981058432: Pacifica-S Implant, 9mm x 20mm x 7mm
• 10889981032951: Pacifica Trial 9mm x 24mm x 17mm, Lordotic
• 10889981032937: Pacifica Trial 9mm x 24mm x 15mm, Lordotic