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
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
K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.2026-09-27
K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.2026-09-23
K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi2026-09-17
K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical2026-09-14
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