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 » Life Spine Grabs Additional 510(k) Clearance for Joint-Fixation System

Life Spine Grabs Additional 510(k) Clearance for Joint-Fixation System

September 25, 2020

Life Spine has received an additional 510(k) clearance for its SImpact Sacroiliac Joint Fixation System, allowing it to be used with longer screws for spinopelvic fixation.

The agency’s clearance adds a 14.5mm-diameter screw size to the system, which fills a gap in the market for revision surgeries, the company said. Previously, the system offered 12mm and 8mm diameter screws.

In addition, all implants in the system are now offered in overall lengths of 30mm to 110mm in 5mm increments, and its 8mm-diameter lag screws now include self-drilling tips to allow for fewer surgical steps.

View today's stories

Medical Devices Submissions and Approvals

Upcoming Events

  • 01Feb

    The Future of QMS: Will the Recent Announcement and Delays Have a Global Impact?

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

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

  • NeuroMetrix Launches DPNCheck 2.0 for Peripheral Neuropathy Screening

  • Syros Gets Fast Track Status for Higher-Risk Myelodysplastic Syndrome Candidate

  • FDA Approves Abbott’s Spinal Cord Stimulation System for Diabetic Peripheral Neuropathy

  • FDA Expands Approval for Merck’s Keytruda in NSCLC

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 or Share My Data
Footer Logo

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

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing