Cleared Special

OrthoButton AL

K230212 · Riverpoint Medical, LLC · Orthopedic
Feb 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K230212 is an FDA 510(k) clearance for the OrthoButton AL, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Riverpoint Medical, LLC (Portland, US). The FDA issued a Cleared decision on February 23, 2023, 28 days after receiving the submission on January 26, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K230212 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2023
Decision Date February 23, 2023
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