The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Matrixmandible Plate And Screw System.
| Device ID | K082335 |
| 510k Number | K082335 |
| Device Name: | SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1301 GOSHEN PKWY. West Chester, PA 19380 |
| Contact | Amnon Talmor |
| Correspondent | Amnon Talmor 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 | 2008-08-14 |
| Decision Date | 2008-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H98004503548050 | K082335 | 000 |
| H98004503546050 | K082335 | 000 |
| H98004503508050 | K082335 | 000 |
| H98004503506050 | K082335 | 000 |
| H98004503548010 | K082335 | 000 |
| H98004503546010 | K082335 | 000 |
| H98004503508010 | K082335 | 000 |
| H98004503506010 | K082335 | 000 |