Cleared Special

INERTIA MIS PEDICLE SCREW SYSTEM

K132412 · Nexxt Spine, LLC · Orthopedic
Oct 2013
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K132412 is an FDA 510(k) clearance for the INERTIA MIS PEDICLE SCREW SYSTEM, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Nexxt Spine, LLC (Washington, US). The FDA issued a Cleared decision on October 10, 2013, 69 days after receiving the submission on August 2, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K132412 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2013
Decision Date October 10, 2013
Days to Decision 69 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

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

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