Cleared Traditional

Ibis? Pedicle Screw System

K162995 · Ortho Development Corporation · Orthopedic

Mar 2017

Decision

154d

Days

Class 2

Risk

About This 510(k) Submission

K162995 is an FDA 510(k) clearance for the Ibis? Pedicle Screw System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Ortho Development Corporation (Draper, US). The FDA issued a Cleared decision on March 30, 2017, 154 days after receiving the submission on October 27, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K162995 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 2016
Decision Date	March 30, 2017
Days to Decision	154 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.