NextAR TKA Platform
K-Number: K202152 · 2020-10-27
ApplicantMedacta International S.A.
Decision Date2020-10-27
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NextAR TKA Platform is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2020-10-27 under approval number K202152. 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?
NextAR TKA Platform is a medical device that received FDA 510(k) clearance on 2020-10-27. It is manufactured by Medacta International S.A.. The 510(k) number is K202152.
When was NextAR TKA Platform approved by the FDA?
NextAR TKA Platform received FDA 510(k) clearance on 2020-10-27, under approval number K202152.
What company makes NextAR TKA Platform?
NextAR TKA Platform is manufactured by Medacta International S.A..
What is the FDA product code for NextAR TKA Platform?
The FDA product code for NextAR TKA Platform is SBF.
Other Devices by Medacta International S.A.
Related Devices (Code: SBF)
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.