FDA device listing
drill bit
FDA device listing 1161084072 · ARTHREX, INC.
Key facts
| Proprietary names | drill bit |
|---|---|
| Owner/operator | ARTHREX, INC. |
| Owner/operator number | 1220287 |
| Product codes | HTW |
| Device names | HTW - Bit, Drill |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | Arthrex Australia Pty Ltd., 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, Arthrex Logistic Center Canada and 4 more |
| Establishment registrations | 1220246, 3002579136, 3007193505, 3009423112, 3010331645, 3011230048, 3013700547, 3014004349, 3014262693, 3015231789, 3015974593, 3016851379, 3019269298, 3021226419, 3027339877, 3030926959 |
| FEI numbers | 1220246, 3002579136, 3007193505, 3009423112, 3010331645, 3011230048, 3013700547, 3014004349, 3014262693, 3015231789, 3015974593, 3016851379, 3019269298, 3021226419, 3027339877, 3030926959 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Manufacturer, 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