Cleared Special

Swedge? Pedicle Screw Fixation System

K230482 · Spinal Resources, Inc. · Orthopedic

Mar 2023

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K230482 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 March 23, 2023, 29 days after receiving the submission on February 22, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K230482 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 22, 2023
Decision Date	March 23, 2023
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.