FDA.reportPublic FDA data

510(k) K242899

Device
NOVA Minimally Invasive System
Applicant
Baui Biotech Co., Ltd.
510(k) number
K242899
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-17
Date received
2024-09-23
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Herman Jhan
Address
6f., #8, Sec.1, Zhongxing Rd., Wugu Dist. New Taipei City TW 24872 24872

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NKB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)2026-05-15
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K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA2026-05-01
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K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.2026-04-28
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K254274ARx® SAI Implant SystemLife Spine, Inc.2026-04-16
K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-04-03
K254247OSTEOMNI SPINAL FIXATION SYSTEMOsteomni, Inc.2026-02-24
K253169Duet™ Spinal Fixation SystemBox Spine, LLC2026-02-23
K253545Vulcan Spinal SystemK2m, Inc.2026-02-10
K252461Swedge™ Pedicle Screw Fixation System Bezier RodSpinal Resources, Inc.2026-01-13
K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-01-07
K253941CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly)Medtronic Sofamor Danek USA, Inc.2026-01-07