NuVasive® Reline® 4.5-5.0 System
K-Number: K170126 · 2017-03-09
ApplicantNu Vasive, Incorporated
Decision Date2017-03-09
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NuVasive® Reline® 4.5-5.0 System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2017-03-09 under approval number K170126. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NuVasive® Reline® 4.5-5.0 System?
NuVasive® Reline® 4.5-5.0 System is a medical device that received FDA 510(k) clearance on 2017-03-09. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K170126.
When was NuVasive® Reline® 4.5-5.0 System approved by the FDA?
NuVasive® Reline® 4.5-5.0 System received FDA 510(k) clearance on 2017-03-09, under approval number K170126.
What company makes NuVasive® Reline® 4.5-5.0 System?
NuVasive® Reline® 4.5-5.0 System is manufactured by Nu Vasive, Incorporated.
What is the FDA product code for NuVasive® Reline® 4.5-5.0 System?
The FDA product code for NuVasive® Reline® 4.5-5.0 System is NKB.
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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.