NEXXT MATRIXX® SI System
K-Number: K243838 · 2025-03-14
ApplicantNexxt Spine
Decision Date2025-03-14
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NEXXT MATRIXX® SI System is a medical device manufactured by Nexxt Spine. It received FDA 510(k) clearance on 2025-03-14 under approval number K243838. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NEXXT MATRIXX® SI System?
NEXXT MATRIXX® SI System is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Nexxt Spine. The 510(k) number is K243838.
When was NEXXT MATRIXX® SI System approved by the FDA?
NEXXT MATRIXX® SI System received FDA 510(k) clearance on 2025-03-14, under approval number K243838.
What company makes NEXXT MATRIXX® SI System?
NEXXT MATRIXX® SI System is manufactured by Nexxt Spine.
What is the FDA product code for NEXXT MATRIXX® SI System?
The FDA product code for NEXXT MATRIXX® SI System is OUR.
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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.