SeaSpine NewPort Spinal System 61-4735

GUDID 10889981138783

Newport 4.75 X 35mm Double Lead Screw

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981138783
• NIH Device Record Key: 40cf2c87-e8ed-4c87-8d6a-ec1c6184b04b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SeaSpine NewPort Spinal System
• Version Model Number: 61-4735
• Catalog Number: 61-4735
• 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: true
• 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	10889981138783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161535

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[10889981138783]

Moist Heat or Steam Sterilization

[10889981138783]

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: 2016-11-30

On-Brand Devices [SeaSpine NewPort Spinal System]

• 10889981138813: Newport 4.75 X 50mm Double Lead Screw
• 10889981138806: Newport 4.75 X 45mm Double Lead Screw
• 10889981138790: Newport 4.75 X 40mm Double Lead Screw
• 10889981138783: Newport 4.75 X 35mm Double Lead Screw
• 10889981138776: Newport 4.75 X 30mm Double Lead Screw
• 10889981129828: 8.5/9.5mm Screw Inserter Sleeve, Containing
• 10889981125776: Newport 4.75mm Screw Caddy
• 10889981125769: Newport 9.5mm Screw Caddy
• 10889981125752: Newport Extension Tray