The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Access To Synthes Ti-6a1-7nb Unreamed Femoral Nail.
| Device ID | K932593 |
| 510k Number | K932593 |
| Device Name: | ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Diane Cochet-wynant |
| Correspondent | Diane Cochet-wynant SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-28 |
| Decision Date | 1994-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794560120 | K932593 | 000 |
| H6794561100 | K932593 | 000 |
| H6794561050 | K932593 | 000 |
| H6794561000 | K932593 | 000 |
| H6794560100 | K932593 | 000 |
| H6794590140 | K932593 | 000 |
| H6794590130 | K932593 | 000 |
| H6794570850 | K932593 | 000 |
| H6794570110 | K932593 | 000 |
| H679456850 | K932593 | 000 |
| H6794560130 | K932593 | 000 |
| H6794560110 | K932593 | 000 |
| H6794572120 | K932593 | 000 |
| H6794572110 | K932593 | 000 |
| H6794572100 | K932593 | 000 |
| H6794561150 | K932593 | 000 |
| H6794561200 | K932593 | 000 |
| H679456700 | K932593 | 000 |
| H679459014S0 | K932593 | 000 |
| H679459013S0 | K932593 | 000 |
| H679457212S0 | K932593 | 000 |
| H679457211S0 | K932593 | 000 |
| H679457012S0 | K932593 | 000 |
| H679457011S0 | K932593 | 000 |
| H679456013S0 | K932593 | 000 |
| H679456012S0 | K932593 | 000 |
| H679456011S0 | K932593 | 000 |
| H679456010S0 | K932593 | 000 |
| H679456950 | K932593 | 000 |
| H679456900 | K932593 | 000 |
| H679456800 | K932593 | 000 |
| H679456750 | K932593 | 000 |
| H6794570120 | K932593 | 000 |