FDA device listing

General orthopedic instruments

FDA device listing 1602001912 · Medacta International SA

Key facts

Proprietary names General orthopedic instruments
Owner/operator Medacta International SA
Owner/operator number 10024526
Product codes FTY
Device names FTY - Tape, Measuring, Rulers And Calipers
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments MEDACTA INTERNATIONAL SA
Establishment registrations 3005180920, 3008110533
FEI numbers 3005180920, 3008110533
Establishment operations Complaint File Establishment, Foreign Exporter
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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