Cleared Traditional

PAGODA PEDICLE SCREW SYSTEM

K131785 · Ortho Development Corp. · Orthopedic

Aug 2013

Decision

63d

Days

Class 2

Risk

About This 510(k) Submission

K131785 is an FDA 510(k) clearance for the PAGODA 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 August 20, 2013, 63 days after receiving the submission on June 18, 2013. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K131785 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2013
Decision Date	August 20, 2013
Days to Decision	63 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.