FDA device listing
ENDOTINE FOREHEAD,ENDOTINE MIDFACE B,ENDOTINE MIDFACE-ST,ENDOTINE TRANSBLEPH,ENDOTINE TRIPLE,Integra Kompressor…
FDA device listing 1237776925 · Sotera Health LLC
Key facts
| Proprietary names | ENDOTINE FOREHEAD,ENDOTINE MIDFACE B,ENDOTINE MIDFACE-ST,ENDOTINE TRANSBLEPH,ENDOTINE TRIPLE,Integra Kompressor Compression Screw System,Kompressor Compression Screw System,MBA Subtalar Implant System,MBA Titanium Subtalar Implant System |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | HWC |
| Device names | HWC - Screw, Fixation, Bone |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3040 |
| Review panels | Orthopedic |
| Registered establishments | Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1036836, 1423662, 2029275 |
| FEI numbers | 1036836, 1000306431, 3000215273 |
| Establishment operations | Contract Sterilizer |
| 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