The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes(r) Titanium Small Reconstruction Plate.
| Device ID | K915818 |
| 510k Number | K915818 |
| Device Name: | SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Diane C Tiernan |
| Correspondent | Diane C Tiernan SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-30 |
| Decision Date | 1992-01-17 |