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FDA 510(k)

NextAR™ Spine Platform

K-Number: K210859 · 2021-11-05

ApplicantMedacta International S.A.
Decision Date2021-11-05
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NextAR™ Spine 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 2021-11-05 under 510(k) number K210859. 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™ Spine Platform?

NextAR™ Spine Platform is a medical device that received FDA 510(k) clearance on 2021-11-05. The listed applicant is Medacta International S.A.. The 510(k) number is K210859.

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

NextAR™ Spine Platform received FDA 510(k) clearance on 2021-11-05, under 510(k) number K210859.

Who is the listed applicant for NextAR™ Spine 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™ Spine Platform?

The FDA product code for NextAR™ Spine Platform is SBF.

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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.

K261854xvision Spine systemAugmedics, Ltd.K253805Knee+Pixee Medical S.A.S.K252847NextAR Hip PlatformMedacta International S.A.K251639xvision Spine systemAugmedics, Ltd.K252054SpineAR SNAP (SyncAR Spine)Surgical Theater, Inc.K252530OptiVu™ ShoulderMr Surgical Solutions, LLC

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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