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FDA 510(k)

NextAR RSA Platform

K-Number: K210153 · 2021-05-12

ApplicantMedacta International S.A.
Decision Date2021-05-12
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NextAR RSA 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 2021-05-12 under 510(k) number K210153. 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 RSA Platform?

NextAR RSA Platform is a medical device that received FDA 510(k) clearance on 2021-05-12. The listed applicant is Medacta International S.A.. The 510(k) number is K210153.

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

NextAR RSA Platform received FDA 510(k) clearance on 2021-05-12, under 510(k) number K210153.

Who is the listed applicant for NextAR RSA 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 RSA Platform?

The FDA product code for NextAR RSA 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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