Tranquil-L Interbody System
K-Number: K233375 · 2024-03-20
ApplicantNexus Spine, LLC
Decision Date2024-03-20
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Tranquil-L Interbody System is a medical device manufactured by Nexus Spine, LLC. It received FDA 510(k) clearance on 2024-03-20 under approval number K233375. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tranquil-L Interbody System?
Tranquil-L Interbody System is a medical device that received FDA 510(k) clearance on 2024-03-20. It is manufactured by Nexus Spine, LLC. The 510(k) number is K233375.
When was Tranquil-L Interbody System approved by the FDA?
Tranquil-L Interbody System received FDA 510(k) clearance on 2024-03-20, under approval number K233375.
What company makes Tranquil-L Interbody System?
Tranquil-L Interbody System is manufactured by Nexus Spine, LLC.
What is the FDA product code for Tranquil-L Interbody System?
The FDA product code for Tranquil-L Interbody System is MAX.
Related Clinical Trials
Other Devices by Nexus Spine, LLC
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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.