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FDA 510(k)

ISS-JAZZ Screw System and JAZZ CAP SP

K-Number: K182771 · 2019-03-12

ApplicantImplanet, S.A.
Decision Date2019-03-12
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ISS-JAZZ Screw System and JAZZ CAP SP is a medical device manufactured by Implanet, S.A.. It received FDA 510(k) clearance on 2019-03-12 under approval number K182771. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISS-JAZZ Screw System and JAZZ CAP SP?

ISS-JAZZ Screw System and JAZZ CAP SP is a medical device that received FDA 510(k) clearance on 2019-03-12. It is manufactured by Implanet, S.A.. The 510(k) number is K182771.

When was ISS-JAZZ Screw System and JAZZ CAP SP approved by the FDA?

ISS-JAZZ Screw System and JAZZ CAP SP received FDA 510(k) clearance on 2019-03-12, under approval number K182771.

What company makes ISS-JAZZ Screw System and JAZZ CAP SP?

ISS-JAZZ Screw System and JAZZ CAP SP is manufactured by Implanet, S.A..

What is the FDA product code for ISS-JAZZ Screw System and JAZZ CAP SP?

The FDA product code for ISS-JAZZ Screw System and JAZZ CAP SP is NKB.

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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

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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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