FDA device listing

Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

FDA device listing 1203809703 · Turnco Tool & Instrument, Inc.

Key facts

Owner/operator Turnco Tool & Instrument, Inc.
Owner/operator number 10042197
Product codes KWS
Device names KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Device class Class II
Classification regulations (21 CFR) 888.3660
Review panels Orthopedic
Registered establishments TURNCO TOOL & INSTRUMENT, INC.
Establishment registrations 3009241418
FEI numbers 3009241418
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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