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FDA 510(k)

PROGENIX PLUS

K-Number: K082002 · 2008-11-24

ApplicantMedtronic Sofamor Danek
Decision Date2008-11-24
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROGENIX PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Sofamor Danek. It received FDA 510(k) clearance on 2008-11-24 under 510(k) number K082002. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGENIX PLUS?

PROGENIX PLUS is a medical device that received FDA 510(k) clearance on 2008-11-24. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K082002.

When did PROGENIX PLUS receive FDA 510(k) clearance?

PROGENIX PLUS received FDA 510(k) clearance on 2008-11-24, under 510(k) number K082002.

Who is the listed applicant for PROGENIX PLUS?

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

What is the FDA product code for PROGENIX PLUS?

The FDA product code for PROGENIX PLUS is MQV.

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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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