FDA.report

510(k) K232097

Device
IdentiTi ALIF Interbody Systems
Applicant
Alphatec Spine, Inc.
510(k) number
K232097
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-25
Date received
2023-07-13
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
Andrew Zhang
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
00190376535111IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535227IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535210IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535203IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535197IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535173IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535166IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535159IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535142IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535135IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535128IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535234IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535104IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535098IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535081IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535067IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535050IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535043IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535036IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535029IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535012IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535005IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535241IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535463IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535456IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535449IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535432IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535425IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535418IdentiTiALPHATEC SPINE, INC.2025-01-22
00190376535401IdentiTiALPHATEC SPINE, INC.2025-01-22

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
K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine2025-09-03
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