The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes 1.0/1.2 Mm Plusdrive Screws.
| Device ID | K042356 |
| 510k Number | K042356 |
| Device Name: | SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS |
| Classification | Screw, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-31 |
| Decision Date | 2004-10-07 |
| Summary: | summary |