FDA device listing
329.632S,329.633S,329.634S,351.013S,351.27S,359.086S,360.01S,GLOBAL AP BALL CYLIN TRL ASSEM,GLOBAL AP REVISION TRL…
FDA device listing 1700508363 · Sotera Health LLC
Key facts
| Proprietary names | 329.632S,329.633S,329.634S,351.013S,351.27S,359.086S,360.01S,GLOBAL AP BALL CYLIN TRL ASSEM,GLOBAL AP REVISION TRL INSERT,GRAFT PASSING GUIDE PIN, STERILE, 2.4 X 432MM (.093 X 17IN),HIGH STRENGTH GUIDE PIN, 12 IN, STERILE, 2.4 X 305MM (.093 X 12IN),HIGH STRENGTH GUIDE PIN, 14 IN, STERILE, 2.4 X 356MM (.093 X 14IN),LCS PAT PLAN REP BASK STD/STD+,MISHA™ Knee System Targeting Kit,MISHA™ Knee System… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | HWT |
| Device names | HWT - Template |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.4800 |
| Review panels | Orthopedic |
| Registered establishments | Sterigenics EO Canada, Inc., Sterigenics U.S. LLC, Sterigenics U.S., LLC, Sterigenics US LLC, Sterigenics US, LLC |
| Establishment registrations | 1058584, 1423662, 1526534, 2022435, 2029275, 2953359, 9611665 |
| FEI numbers | 1526534, 2022435, 1000219637, 1000306431, 3000215205, 3000215273, 3002807095 |
| 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