FDA device listing

System Accessory

FDA device listing 1935479556 · Extremity Medical, LLC

Key facts

Proprietary names System Accessory
Owner/operator Extremity Medical, LLC
Owner/operator number 10027988
Product codes HWT
Device names HWT - Template
Device class Class I
Classification regulations (21 CFR) 888.4800
Review panels Orthopedic
Registered establishments Extremity Medical, LLC
Establishment registrations 3007289093
FEI numbers 3007289093
Establishment operations Complaint File Establishment, Repackager/Relabeler, Specification Developer
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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