FDA 510(k)

Facilis Spinal System

K-Number: K191494 · 2019-08-12

Decision Date2019-08-12

Product CodeNKB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Facilis Spinal System is a medical device manufactured by Baui Biotech Co., Ltd.. It received FDA 510(k) clearance on 2019-08-12 under approval number K191494. 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 Facilis Spinal System?

Facilis Spinal System is a medical device that received FDA 510(k) clearance on 2019-08-12. It is manufactured by Baui Biotech Co., Ltd.. The 510(k) number is K191494.

When was Facilis Spinal System approved by the FDA?

Facilis Spinal System received FDA 510(k) clearance on 2019-08-12, under approval number K191494.

What company makes Facilis Spinal System?

Facilis Spinal System is manufactured by Baui Biotech Co., Ltd..

What is the FDA product code for Facilis Spinal System?

The FDA product code for Facilis Spinal System is NKB.

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Related PubMed Literature

PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Baui Biotech Co., Ltd.

K161231Facilis Spinal System K182416NOVA Minimally Invasive System K191353COMET Lumbar Interbody Fusion Cage K242899NOVA Minimally Invasive System

Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.