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 |