Cleared Special

STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS

K133475 · Nexxt Spine, LLC · Orthopedic
Dec 2013
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K133475 is an FDA 510(k) clearance for the STRUXXURE ANTERIOR CERVICAL PLATE AND SCREWS, 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 December 19, 2013, 37 days after receiving the submission on November 12, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.

Submission Details

510(k) Number K133475 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2013
Decision Date December 19, 2013
Days to Decision 37 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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