Cleared Traditional

All-Suture Anchor

K231078 · Riverpoint Medical, LLC · Orthopedic
Oct 2023
Decision
171d
Days
Class 2
Risk

About This 510(k) Submission

K231078 is an FDA 510(k) clearance for the All-Suture Anchor, 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 October 5, 2023, 171 days after receiving the submission on April 17, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231078 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2023
Decision Date October 05, 2023
Days to Decision 171 days
Submission Type Traditional
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