The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Titanium Diastal Femoral Nail (ti Dfn) System.
| Device ID | K970733 |
| 510k Number | K970733 |
| Device Name: | SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-28 |
| Decision Date | 1997-04-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679040056480 | K970733 | 000 |
| H679040056320 | K970733 | 000 |
| H67904005630S0 | K970733 | 000 |
| H679040056300 | K970733 | 000 |
| H67904005628S0 | K970733 | 000 |
| H679040056280 | K970733 | 000 |
| H67904005626S0 | K970733 | 000 |
| H679040056260 | K970733 | 000 |
| H67904005624S0 | K970733 | 000 |
| H679040056240 | K970733 | 000 |
| H67904005622S0 | K970733 | 000 |
| H679040056220 | K970733 | 000 |
| H67904005620S0 | K970733 | 000 |
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