FDA device listing
Bone Harvester, Bone Tamp,Orthopedic Product
FDA device listing 1476348804 · Suzhou AND Science & Technology Development Corp.
Key facts
| Proprietary names | Bone Harvester, Bone Tamp,Orthopedic Product |
|---|---|
| Owner/operator | Suzhou AND Science & Technology Development Corp. |
| Owner/operator number | 10082136 |
| 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 | SUZHOU AND SCIENCE & TECHNOLOGY DEVELOPMENT CORP. |
| Establishment registrations | 3015356625 |
| FEI numbers | 3015356625 |
| 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