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FDA 510(k)

NextAR™ Spine Platform

K-Number: K233172 · 2024-04-24

Decision Date2024-04-24
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NextAR™ Spine Platform is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2024-04-24 under approval number K233172. 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 2024-04-24. It is manufactured by Medacta International S.A.. The 510(k) number is K233172.

When was NextAR™ Spine Platform approved by the FDA?

NextAR™ Spine Platform received FDA 510(k) clearance on 2024-04-24, under approval number K233172.

What company makes NextAR™ Spine Platform?

NextAR™ Spine Platform is manufactured by Medacta International S.A..

What is the FDA product code for NextAR™ Spine Platform?

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

Other Devices by Medacta International S.A.

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Related Devices (Code: SBF)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.