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FDA 510(k)

JAZZ System, including JAZZ Band

K-Number: K170730 · 2017-06-09

ApplicantImplanet, S.A.
Decision Date2017-06-09
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAZZ System, including JAZZ Band is a medical device manufactured by Implanet, S.A.. It received FDA 510(k) clearance on 2017-06-09 under approval number K170730. 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 System, including JAZZ Band?

JAZZ System, including JAZZ Band is a medical device that received FDA 510(k) clearance on 2017-06-09. It is manufactured by Implanet, S.A.. The 510(k) number is K170730.

When was JAZZ System, including JAZZ Band approved by the FDA?

JAZZ System, including JAZZ Band received FDA 510(k) clearance on 2017-06-09, under approval number K170730.

What company makes JAZZ System, including JAZZ Band?

JAZZ System, including JAZZ Band is manufactured by Implanet, S.A..

What is the FDA product code for JAZZ System, including JAZZ Band?

The FDA product code for JAZZ System, including JAZZ Band is OWI.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025)

Other Devices by Implanet, S.A.

K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector K153348JAZZ LOCK K171881JAZZ Passer Band K162764JAZZ FRAME SYSTEM K192084Madison Total Knee System K191217JAZZ PF

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.

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