The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) 3.5 / 4.5 Mm Lcp Metaphyseal Plates.
| Device ID | K033805 |
| 510k Number | K033805 |
| Device Name: | SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Lisa M Boyle |
| Correspondent | Lisa M Boyle SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | LXT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-08 |
| Decision Date | 2004-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792247650 | K033805 | 000 |
| H6794247540 | K033805 | 000 |
| H6794247550 | K033805 | 000 |
| H6794247560 | K033805 | 000 |
| H6794247570 | K033805 | 000 |
| H6794247580 | K033805 | 000 |
| H6794247590 | K033805 | 000 |
| H6794247610 | K033805 | 000 |
| H6794247630 | K033805 | 000 |
| H6794247530 | K033805 | 000 |
| H6794234180 | K033805 | 000 |
| H6794234070 | K033805 | 000 |
| H6794234080 | K033805 | 000 |
| H6794234090 | K033805 | 000 |
| H6794234100 | K033805 | 000 |
| H6794234110 | K033805 | 000 |
| H6794234120 | K033805 | 000 |
| H6794234140 | K033805 | 000 |
| H6794234160 | K033805 | 000 |
| H6794247650 | K033805 | 000 |
| H6792234060 | K033805 | 000 |
| H6792247540 | K033805 | 000 |
| H6792247550 | K033805 | 000 |
| H6792247560 | K033805 | 000 |
| H6792247570 | K033805 | 000 |
| H6792247580 | K033805 | 000 |
| H6792247590 | K033805 | 000 |
| H6792247610 | K033805 | 000 |
| H6792247630 | K033805 | 000 |
| H6792247530 | K033805 | 000 |
| H6792234180 | K033805 | 000 |
| H6792234070 | K033805 | 000 |
| H6792234080 | K033805 | 000 |
| H6792234090 | K033805 | 000 |
| H6792234100 | K033805 | 000 |
| H6792234110 | K033805 | 000 |
| H6792234120 | K033805 | 000 |
| H6792234140 | K033805 | 000 |
| H6792234160 | K033805 | 000 |
| H6794234060 | K033805 | 000 |