Cleared Traditional

JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector

K160226 · Implanet, S.A. · Orthopedic

May 2016

Decision

110d

Days

Class 2

Risk

About This 510(k) Submission

K160226 is an FDA 510(k) clearance for the JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Implanet, S.A. (Martillac, FR). The FDA issued a Cleared decision on May 18, 2016, 110 days after receiving the submission on January 29, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K160226 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 29, 2016
Decision Date	May 18, 2016
Days to Decision	110 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.