Newport MIS 64-8565

GUDID 10889981125783

NewPort 4mm Hex Screw, DIA 8.5 x 65mm

Seaspine Orthopedics Corporation

Spinal bone screw, non-bioabsorbable

• Primary Device ID: 10889981125783
• NIH Device Record Key: 60b54855-9010-4039-8917-eb95ed542e25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Newport MIS
• Version Model Number: 64-8565
• Catalog Number: 64-8565
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981125783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180176

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

[10889981125783]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-29
• Device Publish Date: 2025-12-19

On-Brand Devices [Newport MIS]

• 10889981125813: NewPort 4mm Hex Screw, DIA 8.5 x 90mm
• 10889981125806: NewPort 4mm Hex Screw, DIA 8.5 x 80mm
• 10889981125790: NewPort 4mm Hex Screw, DIA 8.5 x 70mm
• 10889981125783: NewPort 4mm Hex Screw, DIA 8.5 x 65mm