Cleared Traditional

XIA 4.5 SPINAL SYSTEM

K121342 · Stryker Corp. · Orthopedic

Jun 2012

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K121342 is an FDA 510(k) clearance for the XIA 4.5 SPINAL SYSTEM, 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 June 22, 2012, 49 days after receiving the submission on May 4, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K121342 FDA.gov
FDA Decision	Cleared SESU
Date Received	May 04, 2012
Decision Date	June 22, 2012
Days to Decision	49 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.