The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Orthobutton Fl.
| Device ID | K202399 |
| 510k Number | K202399 |
| Device Name: | OrthoButton FL |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | Riverpoint Medical 825 NE 25th Ave. Portland, OR 97232 |
| Contact | Amanda Cole |
| Correspondent | Amanda Cole Riverpoint Medical 825 NE 25th Ave. Portland, OR 97232 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2020-09-18 |