Granite Point Lock Set Screw

GUDID 00810055525935

Granite Point Lock Set Screw

Si-Bone Inc.

Spinal bone set screw

• Primary Device ID: 00810055525935
• NIH Device Record Key: 4691eef7-5345-485f-bb13-4a8b3c211316
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Granite Point Lock Set Screw
• Version Model Number: 503175
• Company DUNS: 830127168
• Company Name: Si-Bone Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com
• Phone: 855-884-3873
• Email: info@si-bone.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055525935 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220195

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

[00810055525935]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-02
• Device Publish Date: 2025-08-25

Devices Manufactured by Si-Bone Inc.

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• 00810055525935 - Granite Point Lock Set Screw: 2025-09-02 Granite Point Lock Set Screw
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• 00810055524723 - iFuse TORQ TNT Implant System Instrument Tray – 16 mm Washer Caddy: 2024-11-21 iFuse TORQ TNT Implant System Instrument Tray – 16 mm Washer Caddy
• 00810055524730 - iFuse TORQ TNT Implant System Instrument Tray – 21 mm Washer Caddy: 2024-11-21 iFuse TORQ TNT Implant System Instrument Tray – 21 mm Washer Caddy
• 00810055524709 - iFuse TORQ TNT Instrument Tray: 2024-10-03 iFuse TORQ TNT Instrument Tray