iFuse Bedrock Granite Implant System

GUDID 00810055523825

9.5 mm x 60 mm iFuse Bedrock Granite Implant

Si-Bone Inc.

Sacroiliac joint transarticular fixation/arthrodesis implant, coated

• Primary Device ID: 00810055523825
• NIH Device Record Key: 6211f5d9-3232-4213-80d8-f6153966ed7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iFuse Bedrock Granite Implant System
• Version Model Number: 095060BG
• 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
• 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
• 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

• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter
• Outer Diameter: 9.5 Millimeter
• Length: 60 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810055523825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233508

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: 2024-03-25
• Device Publish Date: 2024-03-15

On-Brand Devices [iFuse Bedrock Granite Implant System]

• 00810055523467: Bedrock Granite Standard 12.5 Awl Tip Tap
• 00810055523450: Bedrock Granite Standard 12.0 Awl Tip Tap
• 00810055523443: Bedrock Granite Standard 11.5 Awl Tip Tap
• 00810055523436: Bedrock Granite Standard 11.0 Awl Tip Tap
• 00810055523429: Bedrock Granite Standard 10.5 Awl Tip Tap
• 00810055523412: Bedrock Granite Standard 10.0 Awl Tip Tap
• 00810055523405: Bedrock Granite Standard 9.5 Awl Tip Tap
• 00810055523399: Bedrock Granite Standard 9.0 Awl Tip Tap
• 00810055523382: Bedrock Granite Standard 8.5 Awl Tip Tap
• 00810055523375: Bedrock Granite Standard 12.5 Cannulated Tap
• 00810055523368: Bedrock Granite Standard 12.0 Cannulated Tap
• 00810055523351: Bedrock Granite Standard 11.5 Cannulated Tap
• 00810055523344: Bedrock Granite Standard 11.0 Cannulated Tap
• 00810055523337: Bedrock Granite Standard 10.5 Cannulated Tap
• 00810055523320: Bedrock Granite Standard 10.0 Cannulated Tap
• 00810055523313: Bedrock Granite Standard 9.5 Cannulated Tap
• 00810055523306: Bedrock Granite Standard 9.0 Cannulated Tap
• 00810055523290: Bedrock Granite Standard 8.5 Cannulated Tap
• 00810055523474: Bedrock Granite Standard Locking Driver
• 00810055524112: 9.5 mm x 120 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524105: 9.5 mm x 115 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524099: 9.5 mm x 110 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524082: 9.5 mm x 105 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524075: 9.5 mm x 100 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524068: 9.5 mm x 95 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524051: 9.5 mm x 90 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524044: 9.5 mm x 85 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524037: 9.5 mm x 80 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524020: 9.5 mm x 75 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524013: 9.5 mm x 70 mm iFuse Bedrock Granite Closed Head Implant
• 00810055524006: 9.5 mm x 65 mm iFuse Bedrock Granite Closed Head Implant
• 00810055523993: 9.5 mm x 60 mm iFuse Bedrock Granite Closed Head Implant
• 00810055523986: 9.5 mm x 55 mm iFuse Bedrock Granite Closed Head Implant
• 00810055523979: 9.5 mm x 50 mm iFuse Bedrock Granite Closed Head Implant
• 00810055523962: 9.5 mm x 45 mm iFuse Bedrock Granite Closed Head Implant
• 00810055523955: 9.5 mm x 40 mm iFuse Bedrock Granite Closed Head Implant
• 00810055523948: 9.5 mm x 120 mm iFuse Bedrock Granite Implant
• 00810055523931: 9.5 mm x 115 mm iFuse Bedrock Granite Implant
• 00810055523924: 9.5 mm x 110 mm iFuse Bedrock Granite Implant
• 00810055523917: 9.5 mm x 105 mm iFuse Bedrock Granite Implant
• 00810055523900: 9.5 mm x 100 mm iFuse Bedrock Granite Implant
• 00810055523894: 9.5 mm x 95 mm iFuse Bedrock Granite Implant
• 00810055523887: 9.5 mm x 90 mm iFuse Bedrock Granite Implant
• 00810055523870: 9.5 mm x 85 mm iFuse Bedrock Granite Implant
• 00810055523863: 9.5 mm x 80 mm iFuse Bedrock Granite Implant
• 00810055523856: 9.5 mm x 75 mm iFuse Bedrock Granite Implant
• 00810055523849: 9.5 mm x 70 mm iFuse Bedrock Granite Implant
• 00810055523832: 9.5 mm x 65 mm iFuse Bedrock Granite Implant
• 00810055523825: 9.5 mm x 60 mm iFuse Bedrock Granite Implant
• 00810055523818: 9.5 mm x 55 mm iFuse Bedrock Granite Implant