NuVasive® ACP System
K-Number: K191500 · 2019-09-03
ApplicantNu Vasive, Incorporated
Decision Date2019-09-03
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NuVasive® ACP System is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2019-09-03 under approval number K191500. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NuVasive® ACP System?
NuVasive® ACP System is a medical device that received FDA 510(k) clearance on 2019-09-03. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K191500.
When was NuVasive® ACP System approved by the FDA?
NuVasive® ACP System received FDA 510(k) clearance on 2019-09-03, under approval number K191500.
What company makes NuVasive® ACP System?
NuVasive® ACP System is manufactured by Nu Vasive, Incorporated.
What is the FDA product code for NuVasive® ACP System?
The FDA product code for NuVasive® ACP System is KWQ.
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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.