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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 a medical device manufactured by Medacta Inernational SA. It received FDA 510(k) clearance on 2020-07-10 under approval 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. It is manufactured by Medacta Inernational SA. The 510(k) number is K193559.

When was NextAR TKA Platform approved by the FDA?

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

What company makes NextAR TKA Platform?

NextAR TKA Platform is manufactured by Medacta Inernational SA.

What is the FDA product code for NextAR TKA Platform?

The FDA product code for NextAR TKA Platform is SBF.

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Related Devices (Code: SBF)

K190929xvision Spine system (XVS)Augmedics, Ltd. K202152NextAR TKA PlatformMedacta International S.A. K210859NextAR™ Spine PlatformMedacta International S.A. K211188xvision Spine system (XVS)Augmedics, Ltd. K210153NextAR RSA PlatformMedacta International S.A. K202750Knee+Pixee Medical

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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