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FDA 510(k)

MECRON VOORHOEVE TITANIUM SHEATH

K-Number: K820899 · 1982-05-14

ApplicantSerrano Intl.
Decision Date1982-05-14
Product Code
DecisionSubstantially Equivalent

Device Summary

MECRON VOORHOEVE TITANIUM SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Serrano Intl.. It received FDA 510(k) clearance on 1982-05-14 under 510(k) number K820899. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MECRON VOORHOEVE TITANIUM SHEATH?

MECRON VOORHOEVE TITANIUM SHEATH is a medical device that received FDA 510(k) clearance on 1982-05-14. The listed applicant is Serrano Intl.. The 510(k) number is K820899.

When did MECRON VOORHOEVE TITANIUM SHEATH receive FDA 510(k) clearance?

MECRON VOORHOEVE TITANIUM SHEATH received FDA 510(k) clearance on 1982-05-14, under 510(k) number K820899.

Who is the listed applicant for MECRON VOORHOEVE TITANIUM SHEATH?

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

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Other records listing Serrano Intl. 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.

K851409UNILOC TOTAL HIP PROSTHESISK820619MECRON(R) ACETABULAR NETS TMK820852MECRON CONCAVEX FLEXIBLE INTRAMEDULLARYK810497BONE FIXACTION SCREWK810205MECRON CANCELLOUS CANNULATED BONE SCREWS

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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