NuVasive® Camber Laminoplasty System
K-Number: K191169 · 2019-07-03
ApplicantNu Vasive, Incorporated
Decision Date2019-07-03
Product CodeNQW
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NuVasive® Camber Laminoplasty System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2019-07-03 under approval number K191169. The device is classified under product code NQW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NuVasive® Camber Laminoplasty System?
NuVasive® Camber Laminoplasty System is a medical device that received FDA 510(k) clearance on 2019-07-03. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K191169.
When was NuVasive® Camber Laminoplasty System approved by the FDA?
NuVasive® Camber Laminoplasty System received FDA 510(k) clearance on 2019-07-03, under approval number K191169.
What company makes NuVasive® Camber Laminoplasty System?
NuVasive® Camber Laminoplasty System is manufactured by Nu Vasive, Incorporated.
What is the FDA product code for NuVasive® Camber Laminoplasty System?
The FDA product code for NuVasive® Camber Laminoplasty System is NQW.
Other Devices by Nu Vasive, Incorporated
Related Devices (Code: NQW)
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K171413HAVEN Laminoplasty System, CANOPY® Laminoplasty Fixation SystemGlobus Medical, Inc.
K181717Life Spine Laminoplasty SystemLife Spine, Inc.
K173215Choice Spine Laminoplasty Fixation SystemChoicespine, LP
K191927Hinged Laminoplasty SystemLife Spine, 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.