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FDA 510(k)

JAZZ SYSTEM

K-Number: K121541 · 2012-09-13

ApplicantImplanet, S.A.
Decision Date2012-09-13
Product CodeJDQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

JAZZ SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Implanet, S.A.. It received FDA 510(k) clearance on 2012-09-13 under 510(k) number K121541. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JAZZ SYSTEM?

JAZZ SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-13. The listed applicant is Implanet, S.A.. The 510(k) number is K121541.

When did JAZZ SYSTEM receive FDA 510(k) clearance?

JAZZ SYSTEM received FDA 510(k) clearance on 2012-09-13, under 510(k) number K121541.

Who is the listed applicant for JAZZ SYSTEM?

The FDA 510(k) record lists Implanet, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JAZZ SYSTEM?

The FDA product code for JAZZ SYSTEM is JDQ.

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Other records listing Implanet, S.A. as applicant

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Related Devices (Code: JDQ)

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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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