FDA device listing
HNM Medical Surgical Instrument
FDA device listing 1931216354 · HNM Medical
Key facts
| Proprietary names | HNM Medical Surgical Instrument |
|---|---|
| Owner/operator | HNM Medical |
| Owner/operator number | 10049219 |
| Premarket submissions | K063487 |
| Product codes | KTT |
| Device names | KTT - Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030 |
| Review panels | Orthopedic |
| Registered establishments | HNM Medical dba HNM TOTAL RECON |
| Establishment registrations | 3009513193 |
| FEI numbers | 3009513193 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 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