FDA.reportPublic FDA data

510(k) K200794

Device
AccelFix Spinal Fixation System
Applicant
L&K BIOMED Co., Ltd.
510(k) number
K200794
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2020-10-20
Date received
2020-03-26
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
KiHyang Kim
Address
#201, #202 16-25, Dongbaekjungang-Ro 16 Beon-Gil Giheung-Gu Yongin-Si KR 17015 17015

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