Cleared Special

POWER ADAPTOR INSTRUMENT ACCESSORY

K120434 · Stryker Corp. · Orthopedic

Mar 2012

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K120434 is an FDA 510(k) clearance for the POWER ADAPTOR INSTRUMENT ACCESSORY, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Stryker Corp. (Allendale, US). The FDA issued a Cleared decision on March 8, 2012, 24 days after receiving the submission on February 13, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K120434 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 13, 2012
Decision Date	March 08, 2012
Days to Decision	24 days
Submission Type	Special
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.