Cleared Traditional

Knotless Suture Anchor

K231278 · Riverpoint Medical, LLC · Orthopedic
Aug 2023
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K231278 is an FDA 510(k) clearance for the Knotless 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 August 1, 2023, 90 days after receiving the submission on May 3, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K231278 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2023
Decision Date August 01, 2023
Days to Decision 90 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