The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Matrixmadible Plate And Screw System.
| Device ID | K113567 |
| 510k Number | K113567 |
| Device Name: | SYNTHES MATRIXMADIBLE PLATE AND SCREW SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Alan T Haley |
| Correspondent | Alan T Haley SYNTHES INC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-02 |
| Decision Date | 2012-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980045037890 | K113567 | 000 |
| H980045037880 | K113567 | 000 |
| H980045037870 | K113567 | 000 |
| H980045037860 | K113567 | 000 |
| H980045037850 | K113567 | 000 |