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FDA 510(k)

PROGENIX DBM PUTTY

K-Number: K080462 · 2008-05-13

ApplicantMedtronic Sofamor Danek
Decision Date2008-05-13
Product CodeNUN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROGENIX DBM PUTTY 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 2008-05-13 under 510(k) number K080462. The device is classified under product code NUN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROGENIX DBM PUTTY?

PROGENIX DBM PUTTY is a medical device that received FDA 510(k) clearance on 2008-05-13. The listed applicant is Medtronic Sofamor Danek. The 510(k) number is K080462.

When did PROGENIX DBM PUTTY receive FDA 510(k) clearance?

PROGENIX DBM PUTTY received FDA 510(k) clearance on 2008-05-13, under 510(k) number K080462.

Who is the listed applicant for PROGENIX DBM PUTTY?

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 DBM PUTTY?

The FDA product code for PROGENIX DBM PUTTY is NUN.

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Related Devices (Code: NUN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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