FDA device listing

LEG SUPPORT COMPONENT

FDA device listing 1857110290 · ORTHOFIX SRL

Key facts

Proprietary names LEG SUPPORT COMPONENT
Owner/operator ORTHOFIX SRL
Owner/operator number 9011783
Product codes KQZ
Device names KQZ - Component, Traction, Non-Invasive
Device class Class I
Classification regulations (21 CFR) 888.5890
Review panels Orthopedic
Registered establishments ORTHOFIX SRL
Establishment registrations 9680825
FEI numbers 3002807827
Establishment operations Manufacturer
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

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