iFuse Granite Implant System

GUDID 00810055521326

10.5 mm x 50 mm iFuse Bedrock Granite Implant

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, coated

• Primary Device ID: 00810055521326
• NIH Device Record Key: 481153ff-dc4d-48e3-b285-2fa4a47ea9a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFuse Granite Implant System
• Version Model Number: 105050BG
• 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: true
• 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

Device Dimensions

• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter
• Length: 50 Millimeter
• Outer Diameter: 10.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055521326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220195

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-08
• Device Publish Date: 2022-05-31

On-Brand Devices [iFuse Granite Implant System]

• 00855369008705: Guidewire Driver
• 00810055522149: In-Line Handle, Pinned
• 00810055522132: T-Handle, Pinned
• 00810055522088: Bedrock Granite, Set Screw
• 00810055522071: Bedrock Granite Instrument Set, MIS
• 00810055522064: Bedrock Granite Instrument Set, Open
• 00810055521944: 13.5 mm x 120 mm iFuse Bedrock Granite Implant
• 00810055521937: 13.5 mm x 115 mm iFuse Bedrock Granite Implant
• 00810055521920: 13.5 mm x 110 mm iFuse Bedrock Granite Implant
• 00810055521913: 13.5 mm x 105 mm iFuse Bedrock Granite Implant
• 00810055521906: 13.5 mm x 100 mm iFuse Bedrock Granite Implant
• 00810055521890: 13.5 mm x 95 mm iFuse Bedrock Granite Implant
• 00810055521883: 13.5 mm x 90 mm iFuse Bedrock Granite Implant
• 00810055521876: 13.5 mm x 85 mm iFuse Bedrock Granite Implant
• 00810055521869: 13.5 mm x 80 mm iFuse Bedrock Granite Implant
• 00810055521852: 13.5 mm x 75 mm iFuse Bedrock Granite Implant
• 00810055521845: 13.5 mm x 70 mm iFuse Bedrock Granite Implant
• 00810055521838: 13.5 mm x 65 mm iFuse Bedrock Granite Implant
• 00810055521821: 13.5 mm x 60 mm iFuse Bedrock Granite Implant
• 00810055521814: 13.5 mm x 55 mm iFuse Bedrock Granite Implant
• 00810055521807: 13.5 mm x 50 mm iFuse Bedrock Granite Implant
• 00810055521791: 13.5 mm x 45 mm iFuse Bedrock Granite Implant
• 00810055521784: 12.5 mm x 120 mm iFuse Bedrock Granite Implant
• 00810055521777: 12.5 mm x 115 mm iFuse Bedrock Granite Implant
• 00810055521760: 12.5 mm x 110 mm iFuse Bedrock Granite Implant
• 00810055521753: 12.5 mm x 105 mm iFuse Bedrock Granite Implant
• 00810055521746: 12.5 mm x 100 mm iFuse Bedrock Granite Implant
• 00810055521739: 12.5 mm x 95 mm iFuse Bedrock Granite Implant
• 00810055521722: 12.5 mm x 90 mm iFuse Bedrock Granite Implant
• 00810055521715: 12.5 mm x 85 mm iFuse Bedrock Granite Implant
• 00810055521708: 12.5 mm x 80 mm iFuse Bedrock Granite Implant
• 00810055521692: 12.5 mm x 75 mm iFuse Bedrock Granite Implant
• 00810055521685: 12.5 mm x 70 mm iFuse Bedrock Granite Implant
• 00810055521678: 12.5 mm x 65 mm iFuse Bedrock Granite Implant
• 00810055521661: 12.5 mm x 60 mm iFuse Bedrock Granite Implant
• 00810055521654: 12.5 mm x 55 mm iFuse Bedrock Granite Implant
• 00810055521647: 12.5 mm x 50 mm iFuse Bedrock Granite Implant
• 00810055521630: 12.5 mm x 45 mm iFuse Bedrock Granite Implant
• 00810055521623: 11.5 mm x 120 mm iFuse Bedrock Granite Implant
• 00810055521616: 11.5 mm x 115 mm iFuse Bedrock Granite Implant
• 00810055521609: 11.5 mm x 110 mm iFuse Bedrock Granite Implant
• 00810055521593: 11.5 mm x 105 mm iFuse Bedrock Granite Implant
• 00810055521586: 11.5 mm x 100 mm iFuse Bedrock Granite Implant
• 00810055521579: 11.5 mm x 95 mm iFuse Bedrock Granite Implant
• 00810055521562: 11.5 mm x 90 mm iFuse Bedrock Granite Implant
• 00810055521555: 11.5 mm x 85 mm iFuse Bedrock Granite Implant
• 00810055521548: 11.5 mm x 80 mm iFuse Bedrock Granite Implant
• 00810055521531: 11.5 mm x 75 mm iFuse Bedrock Granite Implant
• 00810055521524: 11.5 mm x 70 mm iFuse Bedrock Granite Implant
• 00810055521517: 11.5 mm x 65 mm iFuse Bedrock Granite Implant