Regatta® Plate RP2-004002

GUDID 10889981319915

Lateral Plate Guide Rod

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10889981319915
• NIH Device Record Key: 38cde2e3-71a6-48e9-989d-d0f68692897c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regatta® Plate
• Version Model Number: RP2-004002
• Catalog Number: RP2-004002
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981319915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200885

FDA Product Code

• KQW: Goniometer, nonpowered

Sterilization

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

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

[10889981319915]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-14
• Device Publish Date: 2024-03-06

On-Brand Devices [Regatta® Plate]

• 10889981319922: Plate Inserter Wrench
• 10889981319915: Lateral Plate Guide Rod
• 10889981319908: Offset Lateral Plate Inserter