FDA device listing

Zimmer

FDA device listing 1161887431 · Zimmer Biomet APAC DFE

Key facts

Proprietary names Zimmer
Owner/operator Zimmer Biomet APAC DFE
Owner/operator number 10056128
Product codes HYA
Device names HYA - Forceps, Wire Holding
Device class Class I
Classification regulations (21 CFR) 878.4800
Review panels General & Plastic Surgery
Registered establishments Zimmer Biomet G.K., Zimmer Biomet Korea Ltd., Zimmer Biomet Pty Ltd, Zimmer Biomet Taiwan Co., Ltd., Zimmer (Shanghai) Medical International Trading Co., Ltd.
Establishment registrations 3011683674, 3012725451, 3015207155, 3015542154, 3035366890
FEI numbers 3011683674, 3012725451, 3015207155, 3015542154, 3035366890
Establishment operations Foreign Exporter
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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