FDA device listing

Mini MaxTorque,PERSONA REVISION KNEE SYSTEM GENERAL

FDA device listing 2002986661 · THE CRETEX COMPANIES, INC.

Key facts

Proprietary names Mini MaxTorque,PERSONA REVISION KNEE SYSTEM GENERAL
Owner/operator THE CRETEX COMPANIES, INC.
Owner/operator number 9001389
Product codes HXX
Device names HXX - Screwdriver
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments rms Surgical
Establishment registrations 3010009693
FEI numbers 3010009693
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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