FDA.reportPublic FDA data

510(k) K230639

Device
Align Cervical Interbody Fusion System
Applicant
Acuity Surgical Devices, LLC
510(k) number
K230639
Product code
ODP
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-01
Date received
2023-03-08
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
No

Applicant Contact#

Contact
Bryan Cowan
Address
8710 N. Royal Ln. Irving TX US 75063 75063

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ODP#

510(k), Device, Applicant table
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