The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (u.s.a.) Polypin.
| Device ID | K961608 |
| 510k Number | K961608 |
| Device Name: | SYNTHES (U.S.A.) POLYPIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Angela J Silvestri |
| Correspondent | Angela J Silvestri 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 | 1996-04-25 |
| Decision Date | 1997-05-09 |
| Summary: | summary |