The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Sternal Fixation System.
| Device ID | K112689 |
| 510k Number | K112689 |
| Device Name: | SYNTHES STERNAL FIXATION SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Elizabeth Kierzek |
| Correspondent | Elizabeth Kierzek SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-15 |
| Decision Date | 2011-10-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980460048S0 | K112689 | 000 |