The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Proximal Tibia Plating System.
| Device ID | K983787 |
| 510k Number | K983787 |
| Device Name: | SYNTHES PROXIMAL TIBIA PLATING 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 | 1998-10-27 |
| Decision Date | 1999-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792400020 | K983787 | 000 |
| H6792400100 | K983787 | 000 |
| H679240010S0 | K983787 | 000 |
| H6792400110 | K983787 | 000 |
| H679240011S0 | K983787 | 000 |
| H6792400120 | K983787 | 000 |
| H679240012S0 | K983787 | 000 |
| H6792400130 | K983787 | 000 |
| H679240013S0 | K983787 | 000 |
| H6792400140 | K983787 | 000 |
| H679240014S0 | K983787 | 000 |
| H6792400150 | K983787 | 000 |
| H679240015S0 | K983787 | 000 |
| H679240009S0 | K983787 | 000 |
| H6792400090 | K983787 | 000 |
| H679240008S0 | K983787 | 000 |
| H679240002S0 | K983787 | 000 |
| H6792400030 | K983787 | 000 |
| H679240003S0 | K983787 | 000 |
| H6792400040 | K983787 | 000 |
| H679240004S0 | K983787 | 000 |
| H6792400050 | K983787 | 000 |
| H679240005S0 | K983787 | 000 |
| H6792400060 | K983787 | 000 |
| H679240006S0 | K983787 | 000 |
| H6792400070 | K983787 | 000 |
| H679240007S0 | K983787 | 000 |
| H6792400080 | K983787 | 000 |
| H6792410040 | K983787 | 000 |
| H6792410050 | K983787 | 000 |
| H679241017S0 | K983787 | 000 |
| H6792400190 | K983787 | 000 |
| H679240019S0 | K983787 | 000 |
| H679241004S0 | K983787 | 000 |
| H679241005S0 | K983787 | 000 |
| H679241006S0 | K983787 | 000 |
| H679241007S0 | K983787 | 000 |
| H679241008S0 | K983787 | 000 |
| H679241009S0 | K983787 | 000 |
| H679241010S0 | K983787 | 000 |
| H679241011S0 | K983787 | 000 |
| H679241012S0 | K983787 | 000 |
| H6792410170 | K983787 | 000 |
| H679241016S0 | K983787 | 000 |
| H6792410160 | K983787 | 000 |
| H6792410060 | K983787 | 000 |
| H6792410070 | K983787 | 000 |
| H6792410080 | K983787 | 000 |
| H6792410090 | K983787 | 000 |
| H6792410100 | K983787 | 000 |
| H6792410110 | K983787 | 000 |
| H6792410120 | K983787 | 000 |
| H6792410130 | K983787 | 000 |
| H6792410140 | K983787 | 000 |
| H679241014S0 | K983787 | 000 |
| H6792410150 | K983787 | 000 |
| H679241015S0 | K983787 | 000 |
| H679241013S0 | K983787 | 000 |