The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Sterile Sternal Fixation System.
| Device ID | K050041 |
| 510k Number | K050041 |
| Device Name: | SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | JDQ |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-07 |
| Decision Date | 2005-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98046002205S0 | K050041 | 000 |
| H980460027S0 | K050041 | 000 |
| H980460028S0 | K050041 | 000 |
| H980460035S0 | K050041 | 000 |
| H980460036S0 | K050041 | 000 |
| H980460037S0 | K050041 | 000 |
| H980460038S0 | K050041 | 000 |
| H980460039S0 | K050041 | 000 |
| H980460040S0 | K050041 | 000 |
| H980460024S0 | K050041 | 000 |