Cleared Traditional

Swedge? Pedicle Screw Fixation System

K170045 · Spinal Resources, Inc. · Orthopedic

Jun 2017

Decision

172d

Days

Class 2

Risk

About This 510(k) Submission

K170045 is an FDA 510(k) clearance for the Swedge? Pedicle Screw Fixation System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Spinal Resources, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on June 26, 2017, 172 days after receiving the submission on January 5, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K170045 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 2017
Decision Date	June 26, 2017
Days to Decision	172 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.