Cleared Traditional

POWEReam Xia/Serrato

K240526 · Stryker Instruments · Orthopedic

Apr 2024

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K240526 is an FDA 510(k) clearance for the POWEReam Xia/Serrato, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on April 29, 2024, 66 days after receiving the submission on February 23, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K240526 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2024
Decision Date	April 29, 2024
Days to Decision	66 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.