510(k) Report

Devices descending from K172064

27 later devices reach Ti-Diagon Oblique TLIF through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+1K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+1K213359SeaSpine WaveForm, C Interbody SystemSeaSpine Orthopedics Corporation20217—
+1K210595SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersCamber Spine Technologies, LLC20213—
+1K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+2K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+2K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+2K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+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—
+2K240566Reef L Interbody System; WaveForm L Interbody SystemSeaSpine Orthopedics Corporation20245—
+2K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+2K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+2K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+2K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+2K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+2K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+3K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+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—
+3K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+3K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+3K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+4K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+5K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—