FDA 510(k)

MectaScrew Extension

K-Number: K203335 · 2022-02-03

Decision Date2022-02-03

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MectaScrew 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 2022-02-03 under 510(k) number K203335. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MectaScrew Extension?

MectaScrew Extension is a medical device that received FDA 510(k) clearance on 2022-02-03. The listed applicant is Medacta International S.A.. The 510(k) number is K203335.

When did MectaScrew Extension receive FDA 510(k) clearance?

MectaScrew Extension received FDA 510(k) clearance on 2022-02-03, under 510(k) number K203335.

Who is the listed applicant for MectaScrew 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 MectaScrew Extension?

The FDA product code for MectaScrew Extension is HWC. This falls under the Cardiovascular category.

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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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.