Cleared Traditional

Aevumed PHANTOM?-LP Suture Anchors

K222363 · Aevumed, Inc. · Orthopedic
Nov 2022
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K222363 is an FDA 510(k) clearance for the Aevumed PHANTOM?-LP 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 November 28, 2022, 116 days after receiving the submission on August 4, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number K222363 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2022
Decision Date November 28, 2022
Days to Decision 116 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