FDA device listing
Arthrex Tibial GraftBolt
FDA device listing 1991797874 · ARTHREX, INC.
Key facts
| Proprietary names | Arthrex Tibial GraftBolt |
|---|---|
| Owner/operator | ARTHREX, INC. |
| Owner/operator number | 1220287 |
| Premarket submissions | K103060 |
| Product codes | MBI |
| Device names | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | Arthrex Australia Pty Ltd., Arthrex Colombia SAS, Arthrex Distribution Hub EMEA B.V., Arthrex, Inc., ARTHREX, INC., Arthrex Korea Ltd., Arthrex Manufacturing Inc., Arthrex Mexico, S.A. de C.V., Arthrex (Shanghai) Co., Ltd., Arthrex Singapore Pte Ltd. |
| Establishment registrations | 1220246, 3010331645, 3011230048, 3013700547, 3014004349, 3014262693, 3015231789, 3016851379, 3019269298, 3021226419 |
| FEI numbers | 1220246, 3010331645, 3011230048, 3013700547, 3014004349, 3014262693, 3015231789, 3016851379, 3019269298, 3021226419 |
| 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 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