FDA device listing
Adjustable Retractor For Blade (For MIS Retractor),Adjustable Retractor For Tube (For MIS Retractor),Blunt Pelvic…
FDA device listing 1882658324 · Miraclus Orthotech Private Limited
Key facts
| Proprietary names | Adjustable Retractor For Blade (For MIS Retractor),Adjustable Retractor For Tube (For MIS Retractor),Blunt Pelvic Retractor,Hohmann Retractor Large (For ASLP-4.5/5.0 ),Hohmann Retractor Large (For Large Fragments ),Hohmann Retractor Small (For ASLP-4.5/5.0 ),Hohmann Retractor Small (For Large Fragments ),Hohmann Retractor, Width 15mm,Nerve Root Retractor,Nerve Root Retractor (For New PLIF… |
|---|---|
| Owner/operator | Miraclus Orthotech Private Limited |
| Owner/operator number | 10093149 |
| Product codes | GAD |
| Device names | GAD - Retractor |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | MIRACLUS ORTHOTECH PRIVATE LIMITED |
| Establishment registrations | 3038187464 |
| FEI numbers | 3038187464 |
| Establishment operations | 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