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FDA 510(k)

MectaLIF Anterior Stand Alone

K-Number: K170455 · 2017-03-16

Decision Date2017-03-16
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaLIF Anterior Stand Alone is the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2017-03-16 under 510(k) number K170455. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MectaLIF Anterior Stand Alone?

MectaLIF Anterior Stand Alone is a medical device that received FDA 510(k) clearance on 2017-03-16. The listed applicant is Medacta International S.A.. The 510(k) number is K170455.

When did MectaLIF Anterior Stand Alone receive FDA 510(k) clearance?

MectaLIF Anterior Stand Alone received FDA 510(k) clearance on 2017-03-16, under 510(k) number K170455.

Who is the listed applicant for MectaLIF Anterior Stand Alone?

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

What is the FDA product code for MectaLIF Anterior Stand Alone?

The FDA product code for MectaLIF Anterior Stand Alone is OVD.

Related Clinical Trials

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.

Other records listing Medacta International S.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: OVD)

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.

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.