Cleared Special

JAZZ Spinal System

K252437 · Implanet · Orthopedic

Aug 2025

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K252437 is an FDA 510(k) clearance for the JAZZ Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Implanet (Allee F. Magendie, FR). The FDA issued a Cleared decision on August 28, 2025, 27 days after receiving the submission on August 1, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K252437 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2025
Decision Date	August 28, 2025
Days to Decision	27 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.