CoRoent® Ti-C System
K-Number: K160916 · 2016-06-28
ApplicantNu Vasive, Incorporated
Decision Date2016-06-28
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
CoRoent® Ti-C System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-06-28 under approval number K160916. 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 CoRoent® Ti-C System?
CoRoent® Ti-C System is a medical device that received FDA 510(k) clearance on 2016-06-28. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K160916.
When was CoRoent® Ti-C System approved by the FDA?
CoRoent® Ti-C System received FDA 510(k) clearance on 2016-06-28, under approval number K160916.
What company makes CoRoent® Ti-C System?
CoRoent® Ti-C System is manufactured by Nu Vasive, Incorporated.
What is the FDA product code for CoRoent® Ti-C System?
The FDA product code for CoRoent® Ti-C System is MAX.
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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.