FDA device listing

& BONE SCREWS,MINI BONE PLATES,TITANIUM,WUERZBURG,WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS

FDA device listing 1130121796 · Zimmer Inc

Key facts

Proprietary names & BONE SCREWS,MINI BONE PLATES,TITANIUM,WUERZBURG,WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWS
Owner/operator Zimmer Inc
Owner/operator number 1825034
Product codes JEY
Device names JEY - Plate, Bone
Device class Class II
Classification regulations (21 CFR) 872.4760
Review panels Dental
Registered establishments BIOMET, INC., Changzhou Biomet Medical Devices Co., Ltd.
Establishment registrations 1825034, 3007923096
FEI numbers 1825034, 3007923096
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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