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FDA 510(k)

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 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 2022-03-10 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K213751.

When did NextAR™ TKA Platform My Knee PPS receive FDA 510(k) clearance?

NextAR™ TKA Platform My Knee PPS received FDA 510(k) clearance on 2022-03-10, under 510(k) number K213751.

Who is the listed applicant for NextAR™ TKA Platform My Knee PPS?

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 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.

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