NOVA Minimally Invasive System

FDA 510(k) K182416 · Baui Biotech Co., Ltd.

Substantially Equivalent

510(k) numberK182416

Submission

Device name
NOVA Minimally Invasive System
Applicant
Baui Biotech Co., Ltd.
New Taipei City, TW
Received
September 4, 2018
Decision date
June 11, 2019
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NKB – Thoracolumbosacral Pedicle Screw System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Specialty
Orthopedic
Implant
Yes

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

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More from L&K BIOMED Co., Ltd.

510(k)DeviceDecision
K242899NOVA Minimally Invasive SystemNKB · Special 10/17/2024SE
K191353COMET Lumbar Interbody Fusion CageMAX · Traditional 04/14/2020SE
K191494Facilis™ Spinal SystemNKB · Special 08/12/2019SE
K161231Facilis™ Spinal SystemNKB · Traditional 01/23/2017SE

Questions and answers

When was NOVA Minimally Invasive System cleared by the FDA?

NOVA Minimally Invasive System (K182416) received a 510(k) decision of Substantially Equivalent on June 11, 2019, 280 days after the submission was received.

What is the product code of K182416?

The FDA product code is NKB – Thoracolumbosacral Pedicle Screw System, a Class II (moderate risk) device regulated under 21 CFR 888.3070.