Cleared Traditional

INERTIA PEDICLE SCREW SYSTEM

K090984 · Nexxt Spine, LLC · Orthopedic
Jun 2009
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K090984 is an FDA 510(k) clearance for the INERTIA PEDICLE SCREW SYSTEM, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Nexxt Spine, LLC (Chesterland, US). The FDA issued a Cleared decision on June 30, 2009, 84 days after receiving the submission on April 7, 2009. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K090984 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2009
Decision Date June 30, 2009
Days to Decision 84 days
Submission Type Traditional
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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