FDA device listing
4.0 SCREW HOLDING SLEEVE,5.0 SCREW HOLDING SLEEVE,DEPTH GAUGE FOR LOCKING SCREWS,DRILL GUIDE BLOCK COMPACT 4 HOLE,DRILL…
FDA device listing 1580734478 · Mawatec AG
Key facts
| Proprietary names | 4.0 SCREW HOLDING SLEEVE,5.0 SCREW HOLDING SLEEVE,DEPTH GAUGE FOR LOCKING SCREWS,DRILL GUIDE BLOCK COMPACT 4 HOLE,DRILL GUIDE BLOCK HII 10 HOLE,DRILL GUIDE BLOCK HII 5 HOLE,DRILL GUIDE FOR CIRCULAR LOCKING HOLES,DRILL GUIDE FOR OBLONG COMPRESSION HOLES,DRILL SLEEVE FOR 4.0 SYSTEM,DRILL SLEEVE FOR 5.0 SYSTEM,DRILL SLEEVE HANDLE,DRILL SLEEVE L=68MM,DRILL SLEEVE SHORT 2.5mm BUTTR,DRILL SLEEVE SHORT… |
|---|---|
| Owner/operator | Mawatec AG |
| Owner/operator number | 10043561 |
| Product codes | LXH |
| Device names | LXH - Orthopedic Manual Surgical Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4540 |
| 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