NuVasive® Reline® 4.5-5.0 System
K-Number: K190636 · 2019-10-19
ApplicantNu Vasive, Incorporated
Decision Date2019-10-19
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 2019-10-19 under approval number K190636. 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 2019-10-19. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K190636.
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 2019-10-19, under approval number K190636.
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.
Other Devices by Nu Vasive, Incorporated
Related Devices (Code: NKB)
K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.
K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC
K162912VIPER PRIME additions to the VIPER® SystemMedos International SARL
K162160Preference Elite Pedicle Screw SystemAmedica Corporation
K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG
K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.
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.