FDA device listing
DORC10527 (VL1) - Tray, Surgical, Instrument,Newclip11561 (MS) - ACTIV Ankle instrumentation set; ACTIV HTO…
FDA device listing 1999890994 · STERIS Corporation
Key facts
| Proprietary names | DORC10527 (VL1) - Tray, Surgical, Instrument,Newclip11561 (MS) - ACTIV Ankle instrumentation set; ACTIV HTO instrumentation set; Activ instrumentation set Base; Acti,Newclip11561 (MS) - Clavicle Distal instrumentation set; Elbow instrumentation set; Foot and Hand Motion,Newclip11561 (MS) - Footmotion instrumentation set; Footmotion Plating System MTP instrumentation set; HammerToe,Newclip11561… |
|---|---|
| Owner/operator | STERIS Corporation |
| Owner/operator number | 10042227 |
| Product codes | FSM |
| Device names | FSM - Tray, Surgical, Instrument |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4800 |
| Review panels | General & Plastic Surgery |
| Registered establishments | STERIS Schweiz AG, Synergy Health Ede BV, Synergy Health Marseille SAS, Synergy Sterilisation (M) Sdn Bhd |
| Establishment registrations | 8043792, 3009337401, 3010162973, 3010220595 |
| FEI numbers | 3002807041, 3002808269, 3009337401, 3010220595 |
| 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