FDA.reportPublic FDA data

510(k) K213653

Device
4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
Applicant
Solco Biomedical Company India Private Limited
510(k) number
K213653
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-19
Date received
2021-11-19
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
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
5 & 6 Third Floorb. Jadav Chambers, Above Sales India Ahmedabad IN 380009 380009

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K254017SWINGO-3D Lumbar Cage SystemImplanet2026-02-26
K253583LUX Expandable Lumbar Interbody SystemXenix Medical2026-02-23
K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.2026-02-04
K253748Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer SystemLife Spine, Inc.2026-01-23
K253266Titanium Interbody SystemSpine Innovation, LLC2026-01-08
K253577IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter)Medicrea International S.A.S. (Medtronic)2025-12-19
K252610ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25
K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28
K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.2025-10-24