FDA device listing
Pinnacle 100 HA Acet Cup,PINNACLE 100 HA ACET CUP,Pinnacle 100 HA Acet Cup 48mm,Pinnacle 100 HA Acet Cup 50mm,Pinnacle…
FDA device listing 1882262516 · Sotera Health LLC
Key facts
| Proprietary names | Pinnacle 100 HA Acet Cup,PINNACLE 100 HA ACET CUP,Pinnacle 100 HA Acet Cup 48mm,Pinnacle 100 HA Acet Cup 50mm,Pinnacle 100 HA Acet Cup 52mm,Pinnacle 100 HA Acet Cup 54mm,Pinnacle 100 HA Acet Cup 58mm,Pinnacle 100 HA Acet Cup 60mm,Pinnacle 100 HA Acet Cup 62mm,Pinnacle 100 HA Acet Cup 64mm,Pinnacle 100 HA Acet Cup 66mm,PINNACLE SECTOR HA ACET CUP,Pinn Sector HA Acet Cup 48mm,Pinn Sector HA Acet Cup… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | LPH |
| Device names | LPH - Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class II |
| Classification regulations (21 CFR) | 888.3358 |
| Review panels | Orthopedic |
| Registered establishments | Sterigenics US, LLC |
| Establishment registrations | 1526534 |
| FEI numbers | 1526534 |
| 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