The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Pilon Plate.
| Device ID | K020602 |
| 510k Number | K020602 |
| Device Name: | SYNTHES PILON PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull SYNTHES 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 | 2002-02-22 |
| Decision Date | 2002-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679SD2411010 | K020602 | 000 |
| H679SD2411000 | K020602 | 000 |
| H6792400830 | K020602 | 000 |
| H6792400820 | K020602 | 000 |