The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Orthobutton Cl.
| Device ID | K160655 |
| 510k Number | K160655 |
| Device Name: | OrthoButton CL |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | RIVERPOINT MEDICAL 825 NE 25TH AVENUE Portland, OR 97232 |
| Contact | Edwin Anderson |
| Correspondent | Edwin Anderson RIVERPOINT MEDICAL 825 NE 25TH AVENUE Portland, OR 97232 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-08 |
| Decision Date | 2016-06-03 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOBUTTON CL 85773600 4364268 Live/Registered |
RIVER POINT, LLC 2012-11-07 |