Cleared Special

INERTIA PEDICLE SCREW SYSTEM

K101278 · Nexxt Spine, LLC · Orthopedic
Dec 2010
Decision
228d
Days
Class 2
Risk

About This 510(k) Submission

K101278 is an FDA 510(k) clearance for the INERTIA PEDICLE SCREW SYSTEM, a Orthosis, Spondylolisthesis Spinal Fixation (Class II — Special Controls, product code MNH), submitted by Nexxt Spine, LLC (Chesterland, US). The FDA issued a Cleared decision on December 20, 2010, 228 days after receiving the submission on May 6, 2010. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K101278 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 2010
Decision Date December 20, 2010
Days to Decision 228 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