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FDA 510(k)

JAZZ FRAME SYSTEM

K-Number: K162764 · 2017-01-19

ApplicantImplanet, S.A.
Decision Date2017-01-19
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAZZ FRAME SYSTEM is a medical device manufactured by Implanet, S.A.. It received FDA 510(k) clearance on 2017-01-19 under approval number K162764. 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 JAZZ FRAME SYSTEM?

JAZZ FRAME SYSTEM is a medical device that received FDA 510(k) clearance on 2017-01-19. It is manufactured by Implanet, S.A.. The 510(k) number is K162764.

When was JAZZ FRAME SYSTEM approved by the FDA?

JAZZ FRAME SYSTEM received FDA 510(k) clearance on 2017-01-19, under approval number K162764.

What company makes JAZZ FRAME SYSTEM?

JAZZ FRAME SYSTEM is manufactured by Implanet, S.A..

What is the FDA product code for JAZZ FRAME SYSTEM?

The FDA product code for JAZZ FRAME SYSTEM is NKB.

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Other Devices by Implanet, S.A.

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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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