The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Scalloped Distal Tibia Plate.
| Device ID | K001793 |
| 510k Number | K001793 |
| Device Name: | SYNTHES SCALLOPED DISTAL TIBIA PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-14 |
| Decision Date | 2000-08-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792400760 | K001793 | 000 |
| H6792400650 | K001793 | 000 |
| H6792400660 | K001793 | 000 |
| H6792400670 | K001793 | 000 |
| H6792400680 | K001793 | 000 |
| H6792400690 | K001793 | 000 |
| H6792400700 | K001793 | 000 |
| H6792400710 | K001793 | 000 |
| H6792400720 | K001793 | 000 |
| H6792400730 | K001793 | 000 |
| H6792400740 | K001793 | 000 |
| H6792400750 | K001793 | 000 |
| H6792400640 | K001793 | 000 |