FDA device listing
INFRAPECTINEAL PLATE LARGE QLS LEFT,INFRAPECTINEAL PLATE LARGE QLS RIGHT,INFRAPECTINEAL PLATE SMALL QLS…
FDA device listing 1152512108 · Mawatec AG
Key facts
| Proprietary names | INFRAPECTINEAL PLATE LARGE QLS LEFT,INFRAPECTINEAL PLATE LARGE QLS RIGHT,INFRAPECTINEAL PLATE SMALL QLS LEFT,INFRAPECTINEAL PLATE SMALL QLS RIGHT,SUPRAPECTINEAL PLATE QLS LEFT,SUPRAPECTINEAL PLATE QLS RIGHT |
|---|---|
| Owner/operator | Mawatec AG |
| Owner/operator number | 10043561 |
| Product codes | HRS, HWC |
| Device names | HRS - Plate, Fixation, Bone, HWC - Screw, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3030, 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | MAWATEC AG |
| Establishment registrations | 3010158639 |
| FEI numbers | 3010158639 |
| 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