VuePoint OCT System
K-Number: K153336 · 2016-01-07
ApplicantNu Vasive, Incorporated
Decision Date2016-01-07
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
VuePoint OCT System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-01-07 under approval number K153336. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VuePoint OCT System?
VuePoint OCT System is a medical device that received FDA 510(k) clearance on 2016-01-07. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K153336.
When was VuePoint OCT System approved by the FDA?
VuePoint OCT System received FDA 510(k) clearance on 2016-01-07, under approval number K153336.
What company makes VuePoint OCT System?
VuePoint OCT System is manufactured by Nu Vasive, Incorporated.
What is the FDA product code for VuePoint OCT System?
The FDA product code for VuePoint OCT System is NKG.
Other Devices by Nu Vasive, Incorporated
Related Devices (Code: NKG)
K161032neon3 universal OCT spinal stabilizationUlrich GmbH & Co. KG
K162300Reform® POCT SystemPrecision Spine, Inc.
K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.
K161591QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.
K161478Xenco Medical Posterior Cervical SystemXenco Medical, LLC
K161498Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, 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.