The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Dhs Helix System.
| Device ID | K981757 |
| 510k Number | K981757 |
| Device Name: | SYNTHES (USA) DHS HELIX SYSTEM |
| Classification | Device, Fixation, Proximal Femoral, Implant |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | JDO |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-19 |
| Decision Date | 1998-07-17 |
| Summary: | summary |