Cleared Special

OrthoButton AL

K171060 · Riverpoint Medical · Orthopedic
Jun 2017
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K171060 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 (Portland, US). The FDA issued a Cleared decision on June 2, 2017, 53 days after receiving the submission on April 10, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K171060 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2017
Decision Date June 02, 2017
Days to Decision 53 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