The following data is part of a premarket notification filed by Synthes (usa) with the FDA for Synthes Button Plate.
| Device ID | K994364 |
| 510k Number | K994364 |
| Device Name: | SYNTHES BUTTON PLATE |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung SYNTHES (USA) 1690 RUSSELL RD. Paoli, PA 19301 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H6794828230 | K994364 | 000 |