The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Matrixmandible Preformed Reconstruction Plates.
| Device ID | K091144 |
| 510k Number | K091144 |
| Device Name: | SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Andrea Tasker |
| Correspondent | Andrea 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 | 2009-04-20 |
| Decision Date | 2009-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980045039050 | K091144 | 000 |
| H980045039040 | K091144 | 000 |
| H980045039030 | K091144 | 000 |
| H980045039020 | K091144 | 000 |
| H980045039010 | K091144 | 000 |
| H980045039000 | K091144 | 000 |