FDA device listing
Bone Drag Hook,Bone Retractor,Bone Spreader,Centrum Spreader,Cervical Retractor,Coxae Drag Hook,Coxae…
FDA device listing 1655450414 · Xinhua Healthcare Industry Co.,Limited
Key facts
| Proprietary names | Bone Drag Hook,Bone Retractor,Bone Spreader,Centrum Spreader,Cervical Retractor,Coxae Drag Hook,Coxae Retractor,Distractor,Joint Retractor,Nerve Root Retravtor,Skin Drag Hook,Tissue Drag Hook,Variable Retractor |
|---|---|
| Owner/operator | Xinhua Healthcare Industry Co.,Limited |
| Owner/operator number | 10055614 |
| Product codes | GAD |
| Device names | GAD - Retractor |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | XINHUA HEALTHCARE INDUSTRY CO.,LIMITED |
| Establishment registrations | 3013875765 |
| FEI numbers | 3013875765 |
| 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