FDA device listing
10mm Black Paddle Scraper,11mm Black Paddle Scraper,12mm Black Paddle Scraper,13mm Black Paddle Scraper,14mm Black…
FDA device listing 2057004374 · Novus Manufacturing Solutions
Key facts
| Proprietary names | 10mm Black Paddle Scraper,11mm Black Paddle Scraper,12mm Black Paddle Scraper,13mm Black Paddle Scraper,14mm Black Paddle Scraper,2.5mm Self Retaining AO Screwdriver,4.5mm Navigated Cannulated Tap,4.5mm Primus Cannulated Tap,5.5mm Navigated Cannulated Tap,5.5mm Primus Cannulated Tap,5mm Black Paddle Scraper,6.5mm Navigated Cannulated Tap,6.5mm Primus Cannulated Tap,6mm Black Paddle Scraper,7.5mm… |
|---|---|
| Owner/operator | Novus Manufacturing Solutions |
| Owner/operator number | 10066039 |
| 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 | NOVUS MANUFACTURING SOLUTIONS |
| Establishment registrations | 3016676864 |
| FEI numbers | 3016676864 |
| 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