Cleared Special

XIA? 4.5 Spinal System, Power Adaptor Instrument Accessory

K172724 · Stryker Corporation · Orthopedic
Oct 2017
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K172724 is an FDA 510(k) clearance for the XIA? 4.5 Spinal System, Power Adaptor Instrument Accessory, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Stryker Corporation (Allendale, US). The FDA issued a Cleared decision on October 10, 2017, 29 days after receiving the submission on September 11, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K172724 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2017
Decision Date October 10, 2017
Days to Decision 29 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.

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