Cleared Traditional

Streamline MIS Spinal Fixation System

K192396 · Pioneer Surgical Technology, Inc. · Orthopedic

Nov 2019

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K192396 is an FDA 510(k) clearance for the Streamline MIS Spinal Fixation System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Pioneer Surgical Technology, Inc. (Marquette, US). The FDA issued a Cleared decision on November 26, 2019, 84 days after receiving the submission on September 3, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K192396 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2019
Decision Date	November 26, 2019
Days to Decision	84 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.