FDA.report

510(k) K251575

Device
IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System
Applicant
Alphatec Spine
510(k) number
K251575
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-03
Date received
2025-05-22
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, 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
00190376700991TranscendALPHATEC SPINE, INC.2025-12-08
00190376687537IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376688695IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376688688IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376700960TranscendALPHATEC SPINE, INC.2025-12-08
00190376700984TranscendALPHATEC SPINE, INC.2025-12-08
00190376687513IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376687520IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376687506IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376662121IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376662114IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376662107IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376662091IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376662084IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376700977TranscendALPHATEC SPINE, INC.2025-12-08
00190376661711IdentiTi IIALPHATEC SPINE, INC.2025-12-08
00190376701004TranscendALPHATEC SPINE, INC.2025-12-08
00190376701011TranscendALPHATEC SPINE, INC.2025-12-08
00190376701028TranscendALPHATEC SPINE, INC.2025-12-08
00190376701035TranscendALPHATEC SPINE, INC.2025-12-08
00190376701042TranscendALPHATEC SPINE, INC.2025-12-08
00190376701059TranscendALPHATEC SPINE, INC.2025-12-08
00190376701066TranscendALPHATEC SPINE, INC.2025-12-08
00190376701073TranscendALPHATEC SPINE, INC.2025-12-08
00190376701080TranscendALPHATEC SPINE, INC.2025-12-08
00190376701097TranscendALPHATEC SPINE, INC.2025-12-08
00190376701103TranscendALPHATEC SPINE, INC.2025-12-08
00190376701110TranscendALPHATEC SPINE, INC.2025-12-08
00190376701127TranscendALPHATEC SPINE, INC.2025-12-08
00190376701134TranscendALPHATEC SPINE, INC.2025-12-08

Other 510(k) Records For Product Code OVD

510(k)DeviceApplicantDecision date
K254202MectaLIF 3D Metal AnteriorMedacta International S.A.2026-05-05
K253401SCRIPT™ Implant SystemGlobus Medical, Inc.2026-04-29
K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.2026-02-25
K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical2025-12-08
K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.2025-07-10
K251644ProAM ALIF SystemPro Surgical, Inc.2025-06-24
K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.2025-06-18
K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC2025-06-12
K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC2025-04-30
K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC2025-04-22
K250603AxTiHA® Stand-Alone ALIF SystemInnovasis2025-03-24
K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2025-03-17
K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2024-12-13
K243191Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc.2024-11-26
K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical2024-10-29