The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes High Tibial Osteotomy (hto) System.
| Device ID | K962894 |
| 510k Number | K962894 |
| Device Name: | SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri 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 | 1996-07-25 |
| Decision Date | 1996-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794142560 | K962894 | 000 |
| H6794142520 | K962894 | 000 |
| H6794142480 | K962894 | 000 |
| H6794142460 | K962894 | 000 |
| H6794142360 | K962894 | 000 |
| H6794142340 | K962894 | 000 |
| H6794142320 | K962894 | 000 |