The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Fixano D.s.s. (double Sliding Screws) System For Osteosynthesis Of Per-trochanteroam Fractures.
| Device ID | K970280 |
| 510k Number | K970280 |
| Device Name: | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Contact | Frank Ferguson |
| Correspondent | Frank Ferguson FERGUSON MEDICAL 3407 BAY AVE. Chico, CA 95973 -8619 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-23 |
| Decision Date | 1997-05-22 |
| Summary: | summary |