FDA device listing
7622-1000-500 LEOS MTP Plate, SM. 0°, Lt,7622-1001-500 MTP FUSION PLATE, MD, 0, LEFT,7622-1003-500 MTP FUSION PLATE…
FDA device listing 1060855741 · Wymed Precision Mechanics
Key facts
| Proprietary names | 7622-1000-500 LEOS MTP Plate, SM. 0°, Lt,7622-1001-500 MTP FUSION PLATE, MD, 0 , LEFT,7622-1003-500 MTP FUSION PLATE, MD, 0 , RIGHT,7622-1050-500 LEOS MTP Plate SM 5° Lt,7622-1052-500 LEOS MTP Fusion Plate, SM, 5°, Rt,7622-1253-500 LEOS MTP Revision Plate, MD, 5°, Rt,77015121-500 Medial Tibia Plate 12H LT,770504050-500 1.5mm/2.0mm Y Tine Plate, 5H,770513060-500 1.5mm/2.0mm Straight Plate Flat… |
|---|---|
| Owner/operator | Wymed Precision Mechanics |
| Owner/operator number | 10043076 |
| Product codes | HRS |
| Device names | HRS - Plate, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030 |
| Review panels | Orthopedic |
| Registered establishments | Wymed Precision Mechanics |
| Establishment registrations | 3003661942 |
| FEI numbers | 3003661942 |
| Establishment operations | Contract 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