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FDA 510(k)

NOVA Minimally Invasive System

K-Number: K242899 · 2024-10-17

ApplicantBaui Biotech Co., Ltd.
Decision Date2024-10-17
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NOVA Minimally Invasive System is the device name listed in this FDA 510(k) record. The listed applicant is Baui Biotech Co., Ltd.. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K242899. 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 2024-10-17. The listed applicant is Baui Biotech Co., Ltd.. The 510(k) number is K242899.

When did NOVA Minimally Invasive System receive FDA 510(k) clearance?

NOVA Minimally Invasive System received FDA 510(k) clearance on 2024-10-17, under 510(k) number K242899.

Who is the listed applicant for NOVA Minimally Invasive System?

The FDA 510(k) record lists Baui Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Baui Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191353COMET Lumbar Interbody Fusion CageK191494Facilis™ Spinal SystemK182416NOVA Minimally Invasive SystemK161231Facilis™ Spinal System

Related Devices (Code: NKB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.K253943Tiger 2 SystemZavation Medical Products, LLCK261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.

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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