The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Matrixmandible Subcondylar Plates.
| Device ID | K091233 |
| 510k Number | K091233 |
| Device Name: | SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Andrea M Tasker |
| Correspondent | Andrea M Tasker SYNTHES (USA) 1301 GOSHEN PKWY. 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 | 2009-04-27 |
| Decision Date | 2009-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980045038340 | K091233 | 000 |
| H980045038330 | K091233 | 000 |
| H980045038320 | K091233 | 000 |
| H980045038310 | K091233 | 000 |
| H980045038300 | K091233 | 000 |