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 |