FDA device listing

CUSTOM MADE UPPER FEMORAL PROSTHESIS

FDA device listing 1831475382 · Adler Ortho S.p.A.

Key facts

Proprietary names CUSTOM MADE UPPER FEMORAL PROSTHESIS
Owner/operator Adler Ortho S.p.A.
Owner/operator number 10086224
Product codes JDD
Device names JDD - Prosthesis, Upper Femoral
Device class Class II
Classification regulations (21 CFR) 888.3360
Review panels Orthopedic
Registered establishments Adler Ortho SpA, ADLER ORTHO S.P.A.
Establishment registrations 3008281151, 3036773273
FEI numbers 3008281151, 3036773273
Establishment operations Contract Manufacturer, 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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