The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Ddhs/dcs System Modification.
| Device ID | K964259 |
| 510k Number | K964259 |
| Device Name: | SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION |
| Classification | Device, Fixation, Proximal Femoral, Implant |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri Musgnung |
| Correspondent | Sheri Musgnung SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | JDO |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-25 |
| Decision Date | 1997-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679280345S0 | K964259 | 000 |
| H679280275S0 | K964259 | 000 |
| H6792802800 | K964259 | 000 |
| H679280280S0 | K964259 | 000 |
| H6792802850 | K964259 | 000 |
| H679280285S0 | K964259 | 000 |
| H6792802900 | K964259 | 000 |
| H679280290S0 | K964259 | 000 |
| H6792802950 | K964259 | 000 |
| H6792802750 | K964259 | 000 |
| H679280270S0 | K964259 | 000 |
| H679280251S0 | K964259 | 000 |
| H6792802550 | K964259 | 000 |
| H679280255S0 | K964259 | 000 |
| H6792802600 | K964259 | 000 |
| H679280260S0 | K964259 | 000 |
| H6792802650 | K964259 | 000 |
| H679280265S0 | K964259 | 000 |
| H6792802700 | K964259 | 000 |
| H679280295S0 | K964259 | 000 |
| H6792803010 | K964259 | 000 |
| H679280325S0 | K964259 | 000 |
| H6792803300 | K964259 | 000 |
| H679280330S0 | K964259 | 000 |
| H6792803350 | K964259 | 000 |
| H679280335S0 | K964259 | 000 |
| H6792803400 | K964259 | 000 |
| H679280340S0 | K964259 | 000 |
| H6792803450 | K964259 | 000 |
| H6792803250 | K964259 | 000 |
| H679280320S0 | K964259 | 000 |
| H679280301S0 | K964259 | 000 |
| H6792803050 | K964259 | 000 |
| H679280305S0 | K964259 | 000 |
| H6792803100 | K964259 | 000 |
| H679280310S0 | K964259 | 000 |
| H6792803150 | K964259 | 000 |
| H679280315S0 | K964259 | 000 |
| H6792803200 | K964259 | 000 |
| H6792802510 | K964259 | 000 |