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 Osteosynthsis Of Unstable Femoral Neck Fractures.
| Device ID | K970258 |
| 510k Number | K970258 |
| Device Name: | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES |
| Classification | Plate, Fixation, Bone |
| 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| 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 |