The following data is part of a premarket notification filed by Synthes with the FDA for Synthes Sternal Fixation System.
| Device ID | K093772 |
| 510k Number | K093772 |
| Device Name: | SYNTHES STERNAL FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker SYNTHES 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-08 |
| Decision Date | 2010-03-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980460172S0 | K093772 | 000 |
| H980460171S0 | K093772 | 000 |