FDA device listing
Suture, Nonabsorbable, Synthetic, Polyethylene
FDA device listing 1924876573 · ARTHREX, INC.
Key facts
| Owner/operator | ARTHREX, INC. |
|---|---|
| Owner/operator number | 1220287 |
| Premarket submissions | K221354 |
| Product codes | GAT |
| Device names | GAT - Suture, Nonabsorbable, Synthetic, Polyethylene |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.5000 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Arthrex Chile SPA, Arthrex Distribution Hub EMEA B.V., Arthrex GmbH, Arthrex, Inc., ARTHREX, INC., Arthrex Manufacturing Inc., Arthrex Mexico, S.A. de C.V., Arthrex New Zealand Limited |
| Establishment registrations | 1220246, 3002579136, 3010331645, 3011230048, 3015231789, 3016851379, 3020704423, 3027339877 |
| FEI numbers | 1220246, 3002579136, 3010331645, 3011230048, 3015231789, 3016851379, 3020704423, 3027339877 |
| Establishment operations | Contract Manufacturer, Contract Sterilizer, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes 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