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FDA 510(k)

MectaLIF Anterior Stand Alone Extension

K-Number: K183426 · 2019-03-15

ApplicantMedacta International S.A.
Decision Date2019-03-15
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MectaLIF Anterior Stand Alone Extension 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 2019-03-15 under 510(k) number K183426. 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 Extension?

MectaLIF Anterior Stand Alone Extension is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Medacta International S.A.. The 510(k) number is K183426.

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

MectaLIF Anterior Stand Alone Extension received FDA 510(k) clearance on 2019-03-15, under 510(k) number K183426.

Who is the listed applicant for MectaLIF Anterior Stand Alone Extension?

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 Extension?

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

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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.

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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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