FDA.report

510(k) K241375

Device
IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi Cervical Porous Ti Interbody System; IdentiTi NanoTec Cervical Interbody System; IdentiTi Cervical Standalone Interbody System; IdentiTi NanoTec Cervical Standalone Interbody System; IdentiTi ALIF Standalone Interbody System; IdentiTi NanoTec ALIF Standalone Interbody System; Transcend PEEK Interbody System; Transcend NanoTec Interbody System; Transcend Cervical PEEK Interbody System; Transcend NanoTec Cer
Applicant
Alphatec Spine
510(k) number
K241375
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-03
Date received
2024-05-15
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
Alanna Joshi
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
00190376700854Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376700830Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376220567IdentiTiALPHATEC SPINE, INC.2026-01-21
00190376700878Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376220680IdentiTiALPHATEC SPINE, INC.2026-01-21
00190376220734IdentiTiALPHATEC SPINE, INC.2026-01-21
00190376700823Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376700779Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376700786Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376220604IdentiTiALPHATEC SPINE, INC.2026-01-21
00190376700731Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376700847Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376700793Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376700755Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376220390IdentiTiALPHATEC SPINE, INC.2026-01-21
00190376220932IdentiTiALPHATEC SPINE, INC.2026-01-21
00190376220512IdentiTiALPHATEC SPINE, INC.2026-01-21
00190376700809Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376700748Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376700861Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376700816Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376220482IdentiTiALPHATEC SPINE, INC.2026-01-21
00190376700724Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376700762Transcend NanoTecALPHATEC SPINE, INC.2026-01-21
00190376666495Transcend NanoTecALPHATEC SPINE, INC.2025-08-14
00190376666488Transcend NanoTecALPHATEC SPINE, INC.2025-08-14
00190376666440Transcend NanoTecALPHATEC SPINE, INC.2025-08-14
00190376666471Transcend NanoTecALPHATEC SPINE, INC.2025-08-14
00190376666464Transcend NanoTecALPHATEC SPINE, INC.2025-08-14
00190376666501Transcend NanoTecALPHATEC SPINE, INC.2025-08-14

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