The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Sterile Button Plate.
| Device ID | K010121 |
| 510k Number | K010121 |
| Device Name: | STERILE BUTTON PLATE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Thomas M Maguire |
| Correspondent | Thomas M Maguire SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-16 |
| Decision Date | 2001-02-09 |