FDA device listing
CB-2 Clamp-Sterilizationcase, 290 x 175 x 33mm,DELTA 1.7MM INSTRUMENT TRAY,DELTA CONTAINER LARGE,DELTA CONTAINER…
FDA device listing 1824768349 · Symmetry Medical Polyvac SAS
Key facts
| Proprietary names | CB-2 Clamp-Sterilizationcase, 290 x 175 x 33mm,DELTA 1.7MM INSTRUMENT TRAY,DELTA CONTAINER LARGE,DELTA CONTAINER SMALL,GENERIC INSTRUMENTS CASE,MID SYSTEM Rack,PiGalileo TKR,PRIMARY ACETABULAR CASE,S-ROM ASIAN EXTRACTOR CASE,S-ROM ASIAN MILLER FRAME CASE,S-ROMASIAN REAMERS CASE,S-ROM FEM INSTR 12-18 CASE |
|---|---|
| Owner/operator | Symmetry Medical Polyvac SAS |
| Owner/operator number | 10042509 |
| 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 | SYMMETRY MEDICAL POLYVAC SAS |
| Establishment registrations | 3008534770 |
| FEI numbers | 3008534770 |
| Establishment operations | Contract Manufacturer, Foreign Exporter |
| 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