Balboa™ 19-5535

GUDID 10889981051822

Buttress Screw, 5.5x35mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981051822
• NIH Device Record Key: e46f16fa-2f46-4fda-a30d-dc15e94ff791
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Balboa™
• Version Model Number: 19-5535
• Catalog Number: 19-5535
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981051822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040130

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

Moist Heat or Steam Sterilization

[10889981051822]

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 [Balboa™]

• 10889981062187: Balboa Implant
• 10889981051846: Buttress Screw 6.5x25mm
• 10889981051839: Buttress Screw 6.5x20mm
• 10889981051822: Buttress Screw, 5.5x35mm
• 10889981051815: Buttress Screw, 5.5x30mm
• 10889981051808: Buttress Screw, 5.5x25mm
• 10889981051792: Buttress Screw, 5.5x20mm
• 10889981051785: Buttress Plate, 15x24mm
• 10889981051778: Buttress Plate, 15x19mm