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FDA 510(k)

NextAR TKA Platform

K-Number: K193559 · 2020-07-10

ApplicantMedacta Inernational SA
Decision Date2020-07-10
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 Inernational SA. It received FDA 510(k) clearance on 2020-07-10 under 510(k) number K193559. 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 2020-07-10. The listed applicant is Medacta Inernational SA. The 510(k) number is K193559.

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

NextAR TKA Platform received FDA 510(k) clearance on 2020-07-10, under 510(k) number K193559.

Who is the listed applicant for NextAR TKA Platform?

The FDA 510(k) record lists Medacta Inernational SA 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.

Other records listing Medacta Inernational SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: SBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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