The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sternal Zipfix System.
| Device ID | K110789 |
| 510k Number | K110789 |
| Device Name: | SYNTHES STERNAL ZIPFIX SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | SYNTHES (USA) 1301 GOSHEN PARKWYA West Chester, PA 19380 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker SYNTHES (USA) 1301 GOSHEN PARKWYA West Chester, PA 19380 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-22 |
| Decision Date | 2011-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9800850100120S0 | K110789 | 000 |
| H9800850100105S0 | K110789 | 000 |
| H9800850100101S0 | K110789 | 000 |
| H980035010800 | K110789 | 000 |