MectaScrew Extension
K-Number: K203335 · 2022-02-03
ApplicantMedacta International S.A.
Decision Date2022-02-03
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MectaScrew Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2022-02-03 under approval 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. It is manufactured by Medacta International S.A.. The 510(k) number is K203335.
When was MectaScrew Extension approved by the FDA?
MectaScrew Extension received FDA 510(k) clearance on 2022-02-03, under approval number K203335.
What company makes MectaScrew Extension?
MectaScrew Extension is manufactured by Medacta International S.A..
What is the FDA product code for MectaScrew Extension?
The FDA product code for MectaScrew Extension is HWC. This falls under the Cardiovascular category.
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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.