FDA.reportPublic FDA data

510(k) K231636

Device
LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
Applicant
L&K BIOMED Co., Ltd.
510(k) number
K231636
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-27
Date received
2023-06-05
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
Katherine Kim
Address
#101, 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
K261217AnyPlus II Spinal Fixation SystemGS Medical Co., Ltd.2026-10-02
K263062NOVIX Pedicle Screw SystemTdm Co., Ltd.2026-10-01
K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC2026-09-30
K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.2026-09-30
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K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-09-04
K253943Tiger 2 SystemZavation Medical Products, LLC2026-07-24
K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.2026-07-24
K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.2026-07-14
K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O2026-07-01
K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.2026-06-17
K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.2026-06-09