NextAR(TM) Spine
K-Number: K250477 · 2025-07-31
ApplicantMedacta International S.A.
Decision Date2025-07-31
Product CodeSBF
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NextAR(TM) Spine is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-07-31 under approval number K250477. 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(TM) Spine?
NextAR(TM) Spine is a medical device that received FDA 510(k) clearance on 2025-07-31. It is manufactured by Medacta International S.A.. The 510(k) number is K250477.
When was NextAR(TM) Spine approved by the FDA?
NextAR(TM) Spine received FDA 510(k) clearance on 2025-07-31, under approval number K250477.
What company makes NextAR(TM) Spine?
NextAR(TM) Spine is manufactured by Medacta International S.A..
What is the FDA product code for NextAR(TM) Spine?
The FDA product code for NextAR(TM) Spine 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.