Cleared Traditional

Swedge? Pedicle Screw Fixation System Bezier Rod

K252461 · Spinal Resources, Inc. · Orthopedic

Jan 2026

Decision

161d

Days

Class 2

Risk

About This 510(k) Submission

K252461 is an FDA 510(k) clearance for the Swedge? Pedicle Screw Fixation System Bezier Rod, 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 January 13, 2026, 161 days after receiving the submission on August 5, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K252461 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 05, 2025
Decision Date	January 13, 2026
Days to Decision	161 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.