Cleared Traditional

POWEReam 1/4 Drive

K233300 · Stryker Instruments · Orthopedic

Dec 2023

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K233300 is an FDA 510(k) clearance for the POWEReam 1/4 Drive, 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 December 26, 2023, 88 days after receiving the submission on September 29, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K233300 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2023
Decision Date	December 26, 2023
Days to Decision	88 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.