Cleared Special

ANAX? 5.5 Spinal System

K162189 · U&I Corporation · Orthopedic
Aug 2016
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K162189 is an FDA 510(k) clearance for the ANAX? 5.5 Spinal System, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by U&I Corporation (Uijeongbu-Si, KR). The FDA issued a Cleared decision on August 30, 2016, 26 days after receiving the submission on August 4, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K162189 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 2016
Decision Date August 30, 2016
Days to Decision 26 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNH — Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070