FDA device listing

Fitbone TAA

FDA device listing 1428261930 · Foreasytech S.r.l.

Key facts

Proprietary names Fitbone TAA
Owner/operator Foreasytech S.r.l.
Owner/operator number 10057004
Product codes HSB
Device names HSB - Rod, Fixation, Intramedullary And Accessories
Device class Class II
Classification regulations (21 CFR) 888.3020
Review panels Orthopedic
Registered establishments FOREASYTECH S.R.L.
Establishment registrations 3012663306
FEI numbers 3012663306
Establishment operations Contract 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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