The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Cranial Plates.
| Device ID | K020087 |
| 510k Number | K020087 |
| Device Name: | SYNTHES CRANIAL PLATES |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Matthew M Hull |
| Correspondent | Matthew M Hull SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-10 |
| Decision Date | 2002-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587054728 | K020087 | 000 |
| H9804460240 | K020087 | 000 |
| H9804460200 | K020087 | 000 |
| H9804210960 | K020087 | 000 |
| H9804210950 | K020087 | 000 |
| H9804210910 | K020087 | 000 |
| H9804210900 | K020087 | 000 |
| H9804210810 | K020087 | 000 |
| H9804210610 | K020087 | 000 |
| H9804210240 | K020087 | 000 |
| H9804466110 | K020087 | 000 |
| H9804466140 | K020087 | 000 |
| 10887587053875 | K020087 | 000 |
| 10887587053837 | K020087 | 000 |
| 10887587053820 | K020087 | 000 |
| 10887587052311 | K020087 | 000 |
| 10887587052304 | K020087 | 000 |
| 10887587052298 | K020087 | 000 |
| 10887587052281 | K020087 | 000 |
| H9804468110 | K020087 | 000 |
| H9804466150 | K020087 | 000 |
| H9804210220 | K020087 | 000 |