Cleared Traditional

Aevumed RAPID Suture Anchors

K223878 · Aevumed, Inc. · Orthopedic
Mar 2023
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K223878 is an FDA 510(k) clearance for the Aevumed RAPID Suture Anchors, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Aevumed, Inc. (Malvern, US). The FDA issued a Cleared decision on March 17, 2023, 80 days after receiving the submission on December 27, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K223878 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 2022
Decision Date March 17, 2023
Days to Decision 80 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