FDA device listing

Screwdriver

FDA device listing 1736185708 · APTIS MEDICAL, LLC.

Key facts

Owner/operator APTIS MEDICAL, LLC.
Owner/operator number 9054354
Product codes HXX
Device names HXX - Screwdriver
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments APTIS MEDICAL, LLC.
Establishment registrations 3004521401
FEI numbers 3004521401
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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