PAO Cortical Screw
K-Number: K211435 · 2021-08-06
ApplicantMedacta International S.A.
Decision Date2021-08-06
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PAO Cortical Screw is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2021-08-06 under approval number K211435. 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 PAO Cortical Screw?
PAO Cortical Screw is a medical device that received FDA 510(k) clearance on 2021-08-06. It is manufactured by Medacta International S.A.. The 510(k) number is K211435.
When was PAO Cortical Screw approved by the FDA?
PAO Cortical Screw received FDA 510(k) clearance on 2021-08-06, under approval number K211435.
What company makes PAO Cortical Screw?
PAO Cortical Screw is manufactured by Medacta International S.A..
What is the FDA product code for PAO Cortical Screw?
The FDA product code for PAO Cortical Screw 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.