FDA device listing
EPM Mueller LTC.; MIS And Mini; Reamer; Reamer ST
FDA device listing 1247095099 · Shanghai Bojin Medical Instrument Co., Ltd.
Key facts
| Proprietary names | EPM Mueller LTC.; MIS And Mini; Reamer; Reamer ST |
|---|---|
| Owner/operator | Shanghai Bojin Medical Instrument Co., Ltd. |
| Owner/operator number | 10091813 |
| Product codes | HTO |
| Device names | HTO - Reamer |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| Review panels | Orthopedic |
| Registered establishments | SHANGHAI BOJIN MEDICAL INSTRUMENT CO., LTD. |
| Establishment registrations | 3037027197 |
| FEI numbers | 3037027197 |
| Establishment operations | 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