The following data is part of a premarket notification filed by Ferguson Medical with the FDA for Fixano D.d.s. (double Sliding Screw).
| Device ID | K954757 |
| 510k Number | K954757 |
| Device Name: | FIXANO D.D.S. (DOUBLE SLIDING SCREW) |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-16 |
| Decision Date | 1996-01-25 |