510(k) Report

Devices descending from K201671

25 later devices reach A-Link Z through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC20252—
+1K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+1K222561AlignAcuity Surgical Devices, LLC202214—
+1K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+1K220610SOLO-LAurora Spine, Inc.20220—
+2K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+2K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+2K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+2K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+2K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+2K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+2K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+2K232432E3D™-A Interbody SystemEvolution Spine20248—
+3K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+3K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+3K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K241846E3D™-C Interbody SystemEvolution Spine20246—
+3K240368E3D™-A Interbody SystemEvolution Spine20247—
+4K262094E3D™-C Interbody SystemEvolution Spine20260—
+4K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K260038E3D™-C Interbody SystemEvolution Spine20261—
+4K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—