The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Automated Tack Driver.
| Device ID | K021382 |
| 510k Number | K021382 |
| Device Name: | SYNTHES (USA) AUTOMATED TACK DRIVER |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Contact | Bonnie J Smith |
| Correspondent | Bonnie J Smith SYNTHES (USA) 1690 RUSSELL RD. P.O. BOX 1766 Paoli, PA 19301 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-02 |
| Decision Date | 2002-05-16 |
| Summary: | summary |