The following data is part of a premarket notification filed by Synthes (usa) with the FDA for 1.3 & 1.5mm Contourable Titanium (ti.) Mesh Plates.
| Device ID | K033121 |
| 510k Number | K033121 |
| Device Name: | 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD Paoli, PA 19301 -1222 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-30 |
| Decision Date | 2003-10-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H9804460550 | K033121 | 000 |
| H9804460150 | K033121 | 000 |
| H9804460140 | K033121 | 000 |
| H9804210200 | K033121 | 000 |
| H9804210170 | K033121 | 000 |
| H9804210150 | K033121 | 000 |
| H9804210090 | K033121 | 000 |
| H980421008S0 | K033121 | 000 |
| H9804210080 | K033121 | 000 |
| H9804210070 | K033121 | 000 |
| H9804210050 | K033121 | 000 |
| H9804460170 | K033121 | 000 |
| H9804460180 | K033121 | 000 |
| H980446054S0 | K033121 | 000 |
| H9804460540 | K033121 | 000 |
| H9804460530 | K033121 | 000 |
| H9804460520 | K033121 | 000 |
| H980446051S0 | K033121 | 000 |
| H980446050S0 | K033121 | 000 |
| H980446036S0 | K033121 | 000 |
| H980446035S0 | K033121 | 000 |
| H980446034S0 | K033121 | 000 |
| H980446033S0 | K033121 | 000 |
| H9804210040 | K033121 | 000 |