Cleared Special

OrthoButton FL

K202399 · Riverpoint Medical · Orthopedic
Sep 2020
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K202399 is an FDA 510(k) clearance for the OrthoButton FL, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Riverpoint Medical (Portland, US). The FDA issued a Cleared decision on September 18, 2020, 28 days after receiving the submission on August 21, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K202399 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2020
Decision Date September 18, 2020
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBI — Fastener, Fixation, Nondegradable, Soft Tissue
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3040