FDA device listing

Trident Acetabular System

FDA device listing 1129472013 · STRYKER CORP.

Key facts

Proprietary names Trident Acetabular System
Owner/operator STRYKER CORP.
Owner/operator number 1811755
Premarket submissions P000013
Product codes MRA
Device names MRA - Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented
Device class Class III
Classification regulations (21 CFR) ORCA1.MRA
Review panels Orthopedic
Registered establishments HOWMEDICA OSTEONICS CORP, STRYKER IRELAND OSTEONICS
Establishment registrations 2249697, 9616680
FEI numbers 3002459190, 3003070421
Establishment operations Manufacturer, Specification Developer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • 100–999 UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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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