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 | K121574 |
| 510k Number | K121574 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-30 |
| Decision Date | 2012-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98004503558050 | K121574 | 000 |
| H98004503556050 | K121574 | 000 |
| H98004503555050 | K121574 | 000 |
| H98004503554050 | K121574 | 000 |
| H98004503558010 | K121574 | 000 |
| H98004503556010 | K121574 | 000 |
| H98004503555010 | K121574 | 000 |
| H98004503554010 | K121574 | 000 |