Cleared Traditional

AEVUMED PHANTOM Suture Anchors

K180464 · Aevumed, Inc. · Orthopedic
May 2018
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K180464 is an FDA 510(k) clearance for the AEVUMED PHANTOM Suture Anchors, a Fastener, Fixation, Nondegradable, Soft Tissue (Class II — Special Controls, product code MBI), submitted by Aevumed, Inc. (Wayne, US). The FDA issued a Cleared decision on May 31, 2018, 99 days after receiving the submission on February 21, 2018. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K180464 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2018
Decision Date May 31, 2018
Days to Decision 99 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