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FDA 510(k)

MENDEC SPINE HV, MENDEC SPINE HV SYSTEM

K-Number: K122175 · 2013-03-28

ApplicantTecres S.P.A.
Decision Date2013-03-28
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MENDEC SPINE HV, MENDEC SPINE HV SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tecres S.P.A.. It received FDA 510(k) clearance on 2013-03-28 under 510(k) number K122175. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENDEC SPINE HV, MENDEC SPINE HV SYSTEM?

MENDEC SPINE HV, MENDEC SPINE HV SYSTEM is a medical device that received FDA 510(k) clearance on 2013-03-28. The listed applicant is Tecres S.P.A.. The 510(k) number is K122175.

When did MENDEC SPINE HV, MENDEC SPINE HV SYSTEM receive FDA 510(k) clearance?

MENDEC SPINE HV, MENDEC SPINE HV SYSTEM received FDA 510(k) clearance on 2013-03-28, under 510(k) number K122175.

Who is the listed applicant for MENDEC SPINE HV, MENDEC SPINE HV SYSTEM?

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

What is the FDA product code for MENDEC SPINE HV, MENDEC SPINE HV SYSTEM?

The FDA product code for MENDEC SPINE HV, MENDEC SPINE HV SYSTEM is NDN.

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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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