The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Elastic Intramedullary Nail (ein) System.
| Device ID | K971783 |
| 510k Number | K971783 |
| Device Name: | SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM |
| Classification | Pin, Fixation, Smooth |
| 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 | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-14 |
| Decision Date | 1997-07-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679475940S0 | K971783 | 000 |
| H679475920S0 | K971783 | 000 |
| H6794759250 | K971783 | 000 |
| H679475925S0 | K971783 | 000 |
| H6794759300 | K971783 | 000 |
| H679475930S0 | K971783 | 000 |
| H6794759350 | K971783 | 000 |
| H679475935S0 | K971783 | 000 |
| H6794759400 | K971783 | 000 |
| H6794759200 | K971783 | 000 |