FDA.report

510(k) K242364

Device
IdentiTi™ II Interbody System
Applicant
Alphatec Spine, Inc.
510(k) number
K242364
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-04
Date received
2024-08-09
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Sandy Gill
Address
1950 Camino Vida Roble Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
00190376722214IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722191IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722030IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376721989IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376721996IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376731995IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376721941IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722054IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722061IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376721965IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722184IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722139IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722146IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722047IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722092IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722207IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722153IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722115IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722016IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376721958IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722078IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722023IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722160IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722108IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722221IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722177IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376721972IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376694375IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722122IdentiTi IIALPHATEC SPINE, INC.2026-02-18
00190376722085IdentiTi IIALPHATEC SPINE, INC.2026-02-18

Other 510(k) Records For Product Code MAX

510(k)DeviceApplicantDecision date
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
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
K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Transforaminal Lumbar Interbody Fusion Cage (TLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Direct Lateral Lumbar Interbody Fusion Cage (DLIF)); Mobarn 80:20 Lumbar Interbody Fusion System (Anterior Lumbar Interbody Fusion Cage (ALIF))Mobarn Medical Devices, LLC2025-09-18
K251444Endoskeleton™ Interbody SystemsMedtronic Sofamor Danek USA, Inc.2025-09-04