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 » Nextremity Solutions Gets 510(k) Clearance for Ankle Fusion Plating System

Nextremity Solutions Gets 510(k) Clearance for Ankle Fusion Plating System

December 30, 2021

Nextremity Solutions has received the FDA’s 510(k) clearance for its Stratum ankle fusion plating system.

Stratum is a comprehensive system of anatomical plates to provide surgeons anterior, lateral and posterior fusion options, the company said.

The system is the latest in the Warsaw, Ind.-based company’s Stratum line, which now includes almost 90 products to treat deformities and fractures in the foot and ankle.

View today's stories

Medical Devices Submissions and Approvals

Upcoming Events

  • 13Jul

    FDA Ad and Promo Enforcement Trends: Past, Present and Future

  • 28Jul

    EU-MDR’s Growing Pains: Are You Current with the Latest Developments?

  • 28Jul

    Is Your Product a Drug or Device — and Does It Matter?: A Recent Appeals Court Decision Says It Does

  • 02Aug

    Medical Device Cybersecurity: Understand the Latest Developments

  • 03Aug

    Pharmaceutical Process Validation: Best Practices for Success

  • 10Aug

    Gene & Cell Therapy Regulation: Comparability and Other New Developments

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

  • FDA Provides Update on GE Healthcare’s Recall of Its Carescape R860 Ventilators

  • Gilead Resubmits NDA for Lenacapavir Following Complete Response Letter

  • FDA Warns Baby Neck Floats Used in Water Therapy Can Cause Death or Injury

  • U.S. Government Inks $3.2 Billion Contract With Pfizer-BioNTech for Vaccine Booster Campaign

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