Cleared Special

Aspiron S ACP System

K220147 · U&I Corporation · Orthopedic
Feb 2022
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K220147 is an FDA 510(k) clearance for the Aspiron S ACP System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on February 16, 2022, 28 days after receiving the submission on January 19, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K220147 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2022
Decision Date February 16, 2022
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWQ — Appliance, Fixation, Spinal Intervertebral Body
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3060

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