Cleared Traditional

JAZZ Spinal System

K240392 · Implanet · Orthopedic

May 2024

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K240392 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 May 6, 2024, 88 days after receiving the submission on February 8, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K240392 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2024
Decision Date	May 06, 2024
Days to Decision	88 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.