The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sternal Fixation System.
| Device ID | K010943 |
| 510k Number | K010943 |
| Device Name: | SYNTHES STERNAL FIXATION SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | JDQ |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-29 |
| Decision Date | 2001-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980413578E0 | K010943 | 000 |
| H9804600280 | K010943 | 000 |
| H9804600350 | K010943 | 000 |
| H9804600360 | K010943 | 000 |
| H9804600370 | K010943 | 000 |
| H9804600380 | K010943 | 000 |
| H9804600390 | K010943 | 000 |
| H9804600400 | K010943 | 000 |
| H9804600450 | K010943 | 000 |
| H980460045S0 | K010943 | 000 |
| H980497690E0 | K010943 | 000 |
| H9804600270 | K010943 | 000 |
| H9804600240 | K010943 | 000 |
| H9804600230 | K010943 | 000 |
| H980413580E0 | K010943 | 000 |
| H980413582E0 | K010943 | 000 |
| H980413584E0 | K010943 | 000 |
| H980413586E0 | K010943 | 000 |
| H980413588E0 | K010943 | 000 |
| H980413590E0 | K010943 | 000 |
| H980413592E0 | K010943 | 000 |
| H980413594E0 | K010943 | 000 |
| H9804600190 | K010943 | 000 |
| H9804600220 | K010943 | 000 |
| H980497691E0 | K010943 | 000 |
| H980497692E0 | K010943 | 000 |
| H9804135920 | K010943 | 000 |
| H9804135940 | K010943 | 000 |
| H9804976900 | K010943 | 000 |
| H9804976910 | K010943 | 000 |
| H9804976920 | K010943 | 000 |
| H9804976930 | K010943 | 000 |
| H9804976940 | K010943 | 000 |
| H9804976950 | K010943 | 000 |
| H9804976960 | K010943 | 000 |
| H9804976970 | K010943 | 000 |
| H9804135900 | K010943 | 000 |
| H9804135880 | K010943 | 000 |
| H9804135860 | K010943 | 000 |
| H980497693E0 | K010943 | 000 |
| H980497694E0 | K010943 | 000 |
| H980497695E0 | K010943 | 000 |
| H980497696E0 | K010943 | 000 |
| H980497697E0 | K010943 | 000 |
| H980497698E0 | K010943 | 000 |
| H9804135780 | K010943 | 000 |
| H9804135800 | K010943 | 000 |
| H9804135820 | K010943 | 000 |
| H9804135840 | K010943 | 000 |
| H9804976980 | K010943 | 000 |