Quadra-P
K-Number: K192827 · 2020-01-06
ApplicantMedacta International S.A.
Decision Date2020-01-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Quadra-P is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-01-06 under approval number K192827. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Quadra-P?
Quadra-P is a medical device that received FDA 510(k) clearance on 2020-01-06. It is manufactured by Medacta International S.A.. The 510(k) number is K192827.
When was Quadra-P approved by the FDA?
Quadra-P received FDA 510(k) clearance on 2020-01-06, under approval number K192827.
What company makes Quadra-P?
Quadra-P is manufactured by Medacta International S.A..
What is the FDA product code for Quadra-P?
The FDA product code for Quadra-P is LZO.
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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.