FDA.report

510(k) K251080

Device
IdentiTi II Cervical Interbody System
Applicant
Alphatec Spine, Inc.
510(k) number
K251080
Product code
ODP
Decision
Substantially Equivalent (SESE)
Decision date
2025-07-03
Date received
2025-04-08
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Cervical
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
Unnati Bhuptani
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
00190376680392ProximityALPHATEC SPINE, INC.2025-12-19
00190376680491ProximityALPHATEC SPINE, INC.2025-12-19
00190376729701ProximityALPHATEC SPINE, INC.2025-12-19
00190376729718ProximityALPHATEC SPINE, INC.2025-12-19
00190376687261IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687285IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376661414Transcend NanoTecALPHATEC SPINE, INC.2025-08-14
00190376661421Transcend NanoTecALPHATEC SPINE, INC.2025-08-14
00190376687223IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687230IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687247IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687254IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687292IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687315IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687308IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687322IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687452IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687339IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687346IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687353IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687360IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687377IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687384IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687391IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687407IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687414IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687421IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687438IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687445IdentiTi IIALPHATEC SPINE, INC.2025-08-14
00190376687469IdentiTi IIALPHATEC SPINE, INC.2025-08-14

Other 510(k) Records For Product Code ODP

510(k)DeviceApplicantDecision date
K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.2026-05-16
K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.2026-05-12
K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.2026-04-24
K253260ORIO-3D Cage SystemSpineCraft2026-04-16
K260340HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGESHC Biologics, LLC2026-04-13
K242303MOD-COrthomod, LLC2026-04-01
K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine2026-03-30
K252432Flex-Z™ Cervical CageSpinepoint, LLC2026-03-25
K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC2026-02-13
K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.2026-01-16
K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.2026-01-15
K252219Cervical Interbody and VBR Fusion SystemSync Surgical2026-01-14
K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies2026-01-08
K252894aprevo® cervical interbody systemCarlsmed, Inc.2026-01-06
K252781MSFX MIKRON PEEK CAGESMikron Makina Sanayi VE Tic. Ltd. Sti.2025-12-19