FDA device listing
130 IN-LB TORQUE WRENCH,AXSOS - INSTRUMENTS,BacFix Ti (Spinal Fixation System),BAYONETED CURETTE DOWN,BAYONETED…
FDA device listing 1065505187 · Tecomet
Key facts
| Proprietary names | 130 IN-LB TORQUE WRENCH,AXSOS - INSTRUMENTS,BacFix Ti (Spinal Fixation System),BAYONETED CURETTE DOWN,BAYONETED CURETTE STRAIGHT,BAYONETED CURETTE UP,BAYONETED KERRISON 2MM 40DEG,BAYONETED KERRISON 2MM 90DEG,BAYONETED KERRISON 2MM UPBITE,BAYONETED KERRISON 3MM 40DEG,BAYONETED KERRISON 3MM 90DEG,BAYONETED KERRISON 4MM 40DEG,BAYONETED KERRISON 4MM 90DEG,BAYONETED KERRISON 4MM … |
|---|---|
| Owner/operator | Tecomet |
| Owner/operator number | 10031318 |
| 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 | TECOMET, INC. |
| Establishment registrations | 2132732 |
| FEI numbers | 1000306694 |
| Establishment operations | Contract Manufacturer, Manufacturer, Repackager/Relabeler, Specification Developer |
| 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