FDA device listing

Camera Heads

FDA device listing 1401594004 · ARTHREX, INC.

Key facts

Proprietary names Camera Heads
Owner/operator ARTHREX, INC.
Owner/operator number 1220287
Product codes KQM
Device names KQM - Camera, Surgical And Accessories
Device class Class I
Classification regulations (21 CFR) 878.4160
Review panels General & Plastic Surgery
Registered establishments Arthrex Australia Pty Ltd., Arthrex California Technology, Incorporated, Arthrex Chile SPA, Arthrex Colombia SAS, Arthrex Distribution Hub EMEA B.V., Arthrex do Brazil Importacao e Comercio de Equipamentos Medicos Ltda, Arthrex GmbH, ARTHREX GMBH, Arthrex, Inc., ARTHREX, INC., Arthrex Korea Ltd., Arthrex Logistic Center Canada and 3 more
Establishment registrations 1220246, 3002579136, 3006990600, 3007193505, 3010331645, 3011230048, 3013700547, 3014004349, 3015974593, 3016851379, 3019269298, 3020704423, 3021226419, 3027339877, 3030926959
FEI numbers 1220246, 3002579136, 3006990600, 3007193505, 3010331645, 3011230048, 3013700547, 3014004349, 3015974593, 3016851379, 3019269298, 3020704423, 3021226419, 3027339877, 3030926959
Establishment operations Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Specification Developer
Registration valid through 2026

At a glance

  • 10–99 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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