The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5/4.5mm Lcp Medial Proximal Tibia Plates.
| Device ID | K050646 |
| 510k Number | K050646 |
| Device Name: | SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Contact | Kathy Anderson |
| Correspondent | Kathy Anderson SYNTHES (USA) 1302 WRIGHTS LANE EAST West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-14 |
| Decision Date | 2005-04-26 |
| Summary: | summary |