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

Other 510(k) Records For Product Code MAX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261049SCALA® TLSpineart SA2026-08-20
K261430TruLift Expandable SystemLife Spine, Inc.2026-07-28
K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.2026-07-17
K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.2026-07-14
K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation2026-07-01
K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.2026-06-15
K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.2026-05-29
K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.2026-05-28
K260506Ventana® P/T Lumbar Interbody SystemSpinal Elements, Inc.2026-05-15
K260837VersaLift Expandable SystemLife Spine, Inc.2026-05-12
K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating systemCarlsmed, Inc.2026-05-09
K261067BEE PLIF CageNGMedical GmbH2026-04-30
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