Cleared Traditional

STRUXXURE?-L and STRUXXURE?-A Plate System

K202192 · Nexxt Spine, LLC · Orthopedic
Sep 2020
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K202192 is an FDA 510(k) clearance for the STRUXXURE?-L and STRUXXURE?-A Plate System, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Nexxt Spine, LLC (Noblesville, US). The FDA issued a Cleared decision on September 17, 2020, 43 days after receiving the submission on August 5, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K202192 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2020
Decision Date September 17, 2020
Days to Decision 43 days
Submission Type Traditional
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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