We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » SI-BONE Gets FDA Clearance for Its iFuse Bedrock Granite for Spinal Treatment

SI-BONE Gets FDA Clearance for Its iFuse Bedrock Granite for Spinal Treatment

June 27, 2022

Santa Clara, Calif.-based SI-BONE has been granted 510(k) premarket clearance by the FDA for its iFuse Bedrock Granite implant system.

The implant, which provides sacroiliac fusion and sacropelvic fixation for spinal fusion procedures, previously received the FDA’s Breakthrough Device designation, as well as a proposal by the Centers for Medicare and Medicaid Services for a new technology add-on payment.

Use of the implant “should lead to fewer reoperations, better patient outcomes, and less cost to the system,” according to Scott Alexander, former vice president of innovation at Mercy Health System, who assessed the product.

SI-BONE specializes in musculoskeletal disorders of the sacropelvic anatomy.

View today's stories

Medical Devices Submissions and Approvals

Upcoming Events

  • 09Aug

    Medical Device Premarket Review Pathways and FDA Mechanisms for Expedited Review

  • 10Aug

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

  • 08Sep

    Organizing Data and Document Archives: Finding a Needle in a Haystack for FDA Inspections

  • 15Sep

    Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

  • 20Sep

    Building a World-Class Pharmaceutical Advertising and Promotion Review Program

  • 22Sep

    FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Bioventus’ neXus SonaStar Elite Gets 510(k) Clearance

  • Civica Launches Its First Lower-Cost Generic Drug

  • Pulse Biosciences’ CellFX Gets 510(k) Clearance for Expanded Energy Settings

  • Merck to Face MDL Regarding Gardasil HPV Vaccine Side Effects

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell My Personal Information
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2022. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing