NextAR TKA Platform My Knee PPS
K-Number: K213751 · 2022-03-10
ApplicantMedacta International S.A.
Decision Date2022-03-10
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NextAR TKA Platform My Knee PPS is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2022-03-10 under approval number K213751. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NextAR TKA Platform My Knee PPS?
NextAR TKA Platform My Knee PPS is a medical device that received FDA 510(k) clearance on 2022-03-10. It is manufactured by Medacta International S.A.. The 510(k) number is K213751.
When was NextAR TKA Platform My Knee PPS approved by the FDA?
NextAR TKA Platform My Knee PPS received FDA 510(k) clearance on 2022-03-10, under approval number K213751.
What company makes NextAR TKA Platform My Knee PPS?
NextAR TKA Platform My Knee PPS is manufactured by Medacta International S.A..
What is the FDA product code for NextAR TKA Platform My Knee PPS?
The FDA product code for NextAR TKA Platform My Knee PPS is SBF.
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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.