Cleared Special

SECULOK? ACP System

K190053 · U&I Corporation · Orthopedic
Feb 2019
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K190053 is an FDA 510(k) clearance for the SECULOK? 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 1, 2019, 21 days after receiving the submission on January 11, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K190053 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2019
Decision Date February 01, 2019
Days to Decision 21 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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