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510(k) K210155

Device
Duo Expandable Interbody Fusion System
Applicant
Spineology Inc.
510(k) number
K210155
Product code
MAX  
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-19
Date received
2021-01-21
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Andrew Adams
Address
7800 3rd St. N. Suite 600 Saint Paul MN US 55128 55128

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
K262572Symmetrix™ PX Spinal SystemMedtronic Sofamor Danek USA, Inc.2026-10-29
K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX Interbody SystemAlphatec Spine, Inc.2026-10-21
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

Legacy Summary#

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FDA Review#

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