The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Modification To Sternal Reconstruction System.
| Device ID | K033816 |
| 510k Number | K033816 |
| Device Name: | SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-09 |
| Decision Date | 2004-03-02 |
| Summary: | summary |