FDA device listing

PRESSURIZER

FDA device listing 2042170317 · Adler Ortho S.p.A.

Key facts

Proprietary names PRESSURIZER
Owner/operator Adler Ortho S.p.A.
Owner/operator number 10086224
Product codes KIH
Device names KIH - Dispenser, Cement
Device class Class I
Classification regulations (21 CFR) 888.4200
Review panels Orthopedic
Registered establishments ADLER ORTHO S.P.A.
Establishment registrations 3008281151
FEI numbers 3008281151
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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