Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

JAZZ PF

K-Number: K191217 · 2019-08-02

ApplicantImplanet, S.A.
Decision Date2019-08-02
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAZZ PF is a medical device manufactured by Implanet, S.A.. It received FDA 510(k) clearance on 2019-08-02 under approval number K191217. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAZZ PF?

JAZZ PF is a medical device that received FDA 510(k) clearance on 2019-08-02. It is manufactured by Implanet, S.A.. The 510(k) number is K191217.

When was JAZZ PF approved by the FDA?

JAZZ PF received FDA 510(k) clearance on 2019-08-02, under approval number K191217.

What company makes JAZZ PF?

JAZZ PF is manufactured by Implanet, S.A..

What is the FDA product code for JAZZ PF?

The FDA product code for JAZZ PF is OWI.

Other Devices by Implanet, S.A.

K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector K153348JAZZ LOCK K171881JAZZ Passer Band K170730JAZZ System, including JAZZ Band K162764JAZZ FRAME SYSTEM K192084Madison Total Knee System

View all 9 devices →

Related Devices (Code: OWI)

K160698LigaPASSMedicrea International SA K161267Response BandLoc Spinal FixationOrthoPediatrics Corp. K161265NuVasive® VersaTie SystemNu Vasive, Incorporated K153348JAZZ LOCKImplanet, S.A. K160208NILE Alternative Fixation Spinal SystemK2m, Inc. K173117NuVasive® VersaTie™ SystemNuvasive, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑