The following data is part of a premarket notification filed by Synthes Inc with the FDA for Synthes Matrixmandible Performed Reconstruction Plates.
| Device ID | K113251 |
| 510k Number | K113251 |
| Device Name: | SYNTHES MATRIXMANDIBLE PERFORMED RECONSTRUCTION PLATES |
| Classification | Plate, Bone |
| Applicant | SYNTHES INC 1302 GOSHEN PARKWAY West Chester, PA 19380 |
| Contact | Alan Haley |
| Correspondent | Alan Haley SYNTHES INC 1302 GOSHEN PARKWAY West Chester, PA 19380 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-03 |
| Decision Date | 2011-12-21 |
| Summary: | summary |