FDA device listing
.060 NK PAT OSTY GD ASSY,11-18007-000-00,11-18008-000-00,11-18142-900-00,11-18146-000-00,1.25mm Cleaning Stylet,1.35mm…
FDA device listing 1937260462 · Tecomet
Key facts
| Proprietary names | .060 NK PAT OSTY GD ASSY,11-18007-000-00,11-18008-000-00,11-18142-900-00,11-18146-000-00,1.25mm Cleaning Stylet,1.35mm Cleaning Brush,1.6mm Adjustable Parallel Wire Guide,2/4 MM TIB DEPTH RES STYLUS,2.7/1.3mm Double Drill Sleeve,3.0/3.5/4.0mm Holding Sleeve,3.0/3.5mm Screw Sizer,3.5mm Cannulated Hex Driver, QC,3.5mm Solid Hex Driver, QC,4.5/3.2mm Double Drill Sleeve,4TH DILATOR… |
|---|---|
| Owner/operator | Tecomet |
| Owner/operator number | 1828464 |
| 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 | SYMMETRY MEDICAL MANUFACTURING INC, SYMMETRY MEDICAL MANUFACTURING INC., SYMMETRY MEDICAL THORNTON PRECISION COMPONENTS LTD |
| Establishment registrations | 1828464, 3004196040, 3005061536 |
| FEI numbers | 1828464, 3004196040, 3005061536 |
| Establishment operations | Contract Manufacturer, 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