The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Modification To Synthes (usa) Polypin.
| Device ID | K003527 |
| 510k Number | K003527 |
| Device Name: | MODIFICATION TO SYNTHES (USA) POLYPIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Thomas M Maguire |
| Correspondent | Thomas M Maguire SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-16 |
| Decision Date | 2001-04-09 |