Cleared Traditional

K153348 - JAZZ LOCK
(FDA 510(k) Clearance)

K153348 · Implanet, S.A. · Orthopedic

Mar 2016

Decision

132d

Days

Class 2

Risk

K153348 is an FDA 510(k) clearance for the JAZZ LOCK. This device is classified as 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 March 31, 2016, 132 days after receiving the submission on November 20, 2015.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3010. 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..

Submission Details

510(k) Number	K153348 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 20, 2015
Decision Date	March 31, 2016
Days to Decision	132 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.