FDA device listing

Medfix® Rongeurs

FDA device listing 1972973079 · Medfix International, LLC

Key facts

Proprietary names Medfix® Rongeurs
Owner/operator Medfix International, LLC
Owner/operator number 10031262
Product codes HTX
Device names HTX - Rongeur
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments Medfix International, LLC
Establishment registrations 3006765019
FEI numbers 3006765019
Establishment operations Repackager/Relabeler
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

Browse all FDA device listings