FDA.reportPublic FDA data

510(k) K232607

Device
4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
Applicant
Solco Biomedical Copany India Private Limited
510(k) number
K232607
Product code
NKB
Decision
Substantially Equivalent (SESE)
Decision date
2024-02-27
Date received
2023-08-28
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
Darshak Shah
Address
Survey #1540, Beside Torrent Pharma, Village-Rajpur Ahmedabad Mehsana Hwy. Kadi IN 382715 382715

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
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K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA2026-05-01
K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.2026-04-29
K253940M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.2026-04-28
K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.2026-04-21
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