NuVasive® VersaTie® System
K-Number: K190418 · 2019-03-21
ApplicantNu Vasive, Incorporated
Decision Date2019-03-21
Product CodeOWI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NuVasive® VersaTie® System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2019-03-21 under approval number K190418. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NuVasive® VersaTie® System?
NuVasive® VersaTie® System is a medical device that received FDA 510(k) clearance on 2019-03-21. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K190418.
When was NuVasive® VersaTie® System approved by the FDA?
NuVasive® VersaTie® System received FDA 510(k) clearance on 2019-03-21, under approval number K190418.
What company makes NuVasive® VersaTie® System?
NuVasive® VersaTie® System is manufactured by Nu Vasive, Incorporated.
What is the FDA product code for NuVasive® VersaTie® System?
The FDA product code for NuVasive® VersaTie® System is OWI.
Other Devices by Nu Vasive, Incorporated
Related Devices (Code: OWI)
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.