The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Sterile Low Profile Neuro Contourable Mesh Plates.
| Device ID | K033160 |
| 510k Number | K033160 |
| Device Name: | SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES |
| Classification | Plate, Bone |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| 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 | 2003-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H980421547S0 | K033160 | 000 |
| H980421532S0 | K033160 | 000 |
| H980421533S0 | K033160 | 000 |
| H980421534S0 | K033160 | 000 |
| H980421535S0 | K033160 | 000 |
| H980421536S0 | K033160 | 000 |
| H980421537S0 | K033160 | 000 |
| H980421538S0 | K033160 | 000 |
| H980421539S0 | K033160 | 000 |
| H980421540S0 | K033160 | 000 |
| H980421541S0 | K033160 | 000 |
| H980421542S0 | K033160 | 000 |
| H980421543S0 | K033160 | 000 |
| H980421544S0 | K033160 | 000 |
| H980421545S0 | K033160 | 000 |
| H980421546S0 | K033160 | 000 |
| H980421531S0 | K033160 | 000 |