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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2020-10-27 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K202152.

When did NextAR TKA Platform receive FDA 510(k) clearance?

NextAR TKA Platform received FDA 510(k) clearance on 2020-10-27, under 510(k) number K202152.

Who is the listed applicant for NextAR TKA Platform?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NextAR TKA Platform?

The FDA product code for NextAR TKA Platform 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.

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