Orientation Guide

GUDID 00810055522828

Orientation Guide

Si-Bone Inc.

Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable Orthopaedic implantation sleeve, reusable

• Primary Device ID: 00810055522828
• NIH Device Record Key: 52413e3b-ff30-4b52-a058-7b87376a58ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orientation Guide
• Version Model Number: 501824
• Company DUNS: 830127168
• Company Name: Si-Bone Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Conditional
• 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: 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
• 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	00810055522828 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

[00810055522828]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-11
• Device Publish Date: 2024-01-03

Devices Manufactured by Si-Bone Inc.

• 00810055524457 - iFuse Granite Implant System-iFuse-Granite+ Instrument Set: 2024-05-29 Granite+ Instrument Set
• 00810055524563 - 8-Gauge Bone Access Needle and Tamp: 2024-05-22 8-Gauge Bone Access Needle and Tamp
• 00810055524617 - iFuse INTRA X Instrument Set: 2024-05-22 iFuse INTRA X Instrument Set
• 00810055523788 - iFuse Bedrock Granite Implant System: 2024-03-25 9.5 mm x 40 mm iFuse Bedrock Granite Implant
• 00810055523795 - iFuse Bedrock Granite Implant System: 2024-03-25 9.5 mm x 45 mm iFuse Bedrock Granite Implant
• 00810055523801 - iFuse Bedrock Granite Implant System: 2024-03-25 9.5 mm x 50 mm iFuse Bedrock Granite Implant
• 00810055523818 - iFuse Bedrock Granite Implant System: 2024-03-25 9.5 mm x 55 mm iFuse Bedrock Granite Implant
• 00810055523825 - iFuse Bedrock Granite Implant System: 2024-03-25 9.5 mm x 60 mm iFuse Bedrock Granite Implant