The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes (usa) Wrist Fusion Plates (wfp).
| Device ID | K000558 |
| 510k Number | K000558 |
| Device Name: | SYNTHES (USA) WRIST FUSION PLATES (WFP) |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. POST OFFICE BOX 1766 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 | 2000-02-18 |
| Decision Date | 2000-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6792425300 | K000558 | 000 |
| H6792425200 | K000558 | 000 |
| H6792425100 | K000558 | 000 |