The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes High Tibial Osteotomy Plate.
| Device ID | K014197 |
| 510k Number | K014197 |
| Device Name: | SYNTHES HIGH TIBIAL OSTEOTOMY PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull SYNTHES (USA) 1690 RUSSELL RD. 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 | 2001-12-21 |
| Decision Date | 2002-03-21 |
| Summary: | summary |