FDA device listing

Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

FDA device listing 1950049895 · PPD MEDITECH, div. of INDUSTRIES PPD INC.

Key facts

Owner/operator PPD MEDITECH, div. of INDUSTRIES PPD INC.
Owner/operator number 10043654
Product codes NPJ
Device names NPJ - Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device class Class II
Classification regulations (21 CFR) 888.3560
Review panels Orthopedic
Registered establishments PPD MEDITECH, DIV. OF INDUSTRIES PPD INC.
Establishment registrations 3010375065
FEI numbers 3010375065
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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