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FDA 510(k)

FUSIONSYNC, CHIMAERA FUSIONSYNC

K-Number: K132963 · 2013-12-16

ApplicantChimaera GmbH
Decision Date2013-12-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUSIONSYNC, CHIMAERA FUSIONSYNC is the device name listed in this FDA 510(k) record. The listed applicant is Chimaera GmbH. It received FDA 510(k) clearance on 2013-12-16 under 510(k) number K132963. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUSIONSYNC, CHIMAERA FUSIONSYNC?

FUSIONSYNC, CHIMAERA FUSIONSYNC is a medical device that received FDA 510(k) clearance on 2013-12-16. The listed applicant is Chimaera GmbH. The 510(k) number is K132963.

When did FUSIONSYNC, CHIMAERA FUSIONSYNC receive FDA 510(k) clearance?

FUSIONSYNC, CHIMAERA FUSIONSYNC received FDA 510(k) clearance on 2013-12-16, under 510(k) number K132963.

Who is the listed applicant for FUSIONSYNC, CHIMAERA FUSIONSYNC?

The FDA 510(k) record lists Chimaera GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUSIONSYNC, CHIMAERA FUSIONSYNC?

The FDA product code for FUSIONSYNC, CHIMAERA FUSIONSYNC is LLZ.

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Official Source

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

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