Cleared Traditional

JAZZ PF

K191217 · Implanet, S.A. · Orthopedic

Aug 2019

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K191217 is an FDA 510(k) clearance for the JAZZ PF, 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 August 2, 2019, 88 days after receiving the submission on May 6, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number	K191217 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2019
Decision Date	August 02, 2019
Days to Decision	88 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.