The following data is part of a premarket notification filed by Riverpoint Medical with the FDA for Juggerknot Soft Anchor.
Device ID | K203740 |
510k Number | K203740 |
Device Name: | JuggerKnot Soft Anchor |
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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-12-22 |
Decision Date | 2021-02-12 |