Cleared Traditional

IBIS PEDICLE SCREW SYSTEM

K142146 · Ortho Development Corp. · Orthopedic

Dec 2014

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K142146 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 Corp. (Draper, US). The FDA issued a Cleared decision on December 11, 2014, 128 days after receiving the submission on August 5, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K142146 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2014
Decision Date	December 11, 2014
Days to Decision	128 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.