Cleared Traditional

K143759 - JAZZ System
(FDA 510(k) Clearance)

K143759 · Implanet, S.A. · Orthopedic

May 2015

Decision

127d

Days

Class 2

Risk

K143759 is an FDA 510(k) clearance for the JAZZ System, a Bone Fixation Cerclage, Sublaminar (Class II — Special Controls, product code OWI), submitted by Implanet, S.A. (Martillac, FR). The FDA issued a Cleared decision on May 7, 2015, 127 days after receiving the submission on December 31, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K143759 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 31, 2014
Decision Date	May 07, 2015
Days to Decision	127 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OWI — Bone Fixation Cerclage, Sublaminar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3010
Definition	Acts As A Bone Anchor For Temporary Stabilization, Or Used In Conjunction With Other Medical Implants Of Similar Metals When Wiring Is Needed, During Development Of A Spinal Fusion.