The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Anterolateral Calcaneal Plate.
| Device ID | K010518 |
| 510k Number | K010518 |
| Device Name: | SYNTHES ANTEROLATERAL CALCANEAL PLATE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Thomas M Maguire |
| Correspondent | Thomas M Maguire SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-22 |
| Decision Date | 2001-05-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H679SD2410010 | K010518 | 000 |