FDA.reportPublic FDA data

510(k) K243004

Device
Xpine Spinal Fixation System
Applicant
Jeil Medical Corporation
510(k) number
K243004
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-08
Date received
2024-09-26
Regulation
888.3070
Classification name
Thoracolumbosacral Pedicle Screw System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jinwoo Kim Kim
Address
702•703•704•705•706•804•805•807•812•815-Ho, 55 Digital-Ro 34-Gil, Guro-Gu Seoul KR 08378 08378

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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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