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FDA 510(k)

MENDEC SPINE

K-Number: K042415 · 2005-06-09

ApplicantTecres S.P.A.
Decision Date2005-06-09
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MENDEC SPINE 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 2005-06-09 under 510(k) number K042415. 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?

MENDEC SPINE is a medical device that received FDA 510(k) clearance on 2005-06-09. The listed applicant is Tecres S.P.A.. The 510(k) number is K042415.

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

MENDEC SPINE received FDA 510(k) clearance on 2005-06-09, under 510(k) number K042415.

Who is the listed applicant for MENDEC SPINE?

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?

The FDA product code for MENDEC SPINE is NDN.

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Other records listing Tecres S.P.A. as applicant

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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Related Devices (Code: 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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