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FDA 510(k)

NOVA Minimally Invasive System

K-Number: K182416 · 2019-06-11

ApplicantBaui Biotech Co., Ltd.
Decision Date2019-06-11
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVA Minimally Invasive System is a medical device manufactured by Baui Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-06-11 under approval number K182416. 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 NOVA Minimally Invasive System?

NOVA Minimally Invasive System is a medical device that received FDA 510(k) clearance on 2019-06-11. It is manufactured by Baui Biotech Co., Ltd.. The 510(k) number is K182416.

When was NOVA Minimally Invasive System approved by the FDA?

NOVA Minimally Invasive System received FDA 510(k) clearance on 2019-06-11, under approval number K182416.

What company makes NOVA Minimally Invasive System?

NOVA Minimally Invasive System is manufactured by Baui Biotech Co., Ltd..

What is the FDA product code for NOVA Minimally Invasive System?

The FDA product code for NOVA Minimally Invasive System is NKB.

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Related PubMed Literature

PMID: 41886403 Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023. Urology practice (2026) PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026) PMID: 40856794 [Translational challenges and clinical potential of artificial intelligence in minimally invasive surgery]. Chirurgie (Heidelberg, Germany) (2025) PMID: 40054052 Development of medical devices driven by academia-industry collaboration: An internal audit. Surgery (2025)

Other Devices by Baui Biotech Co., Ltd.

K161231Facilis™ Spinal System K191494Facilis™ Spinal System K191353COMET Lumbar Interbody Fusion Cage K242899NOVA Minimally Invasive System

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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.

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