510(k) Report

Devices descending from K160154

63 later devices reach ALTA Anterior Cervical Interbody Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222874CarboClear Cervical Cage System, CarboClear Cervical VBR SystemCarbofix Orthpedics, Ltd.20230—
+1K202065DOLOMITE Anterior Cervical Stabilization SystemAstura Medical, LLC20203—
+1K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC20193—
+1K173324ALTA Anterior Cervical Interbody SpacerAstura Medical201827—
+1K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+2K233359DOMINION Expandable Corpectomy SystemAstura Medical20242—
+2K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+2K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20233—
+2K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+2K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K201287Impulse Interbody Fusion SystemDegen Medical20208—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K191822Nano FortiCore, FortiCoreNanovis, LLC20192—
+2K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+2K182477Cervical SpacerAdditive Implants, LLC201915—
+3K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+3K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+3K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemCuriteva, Inc.20260—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+3K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+3K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.20241—
+3K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+3K241605Adaptix™ PEEK Interbody System with Nanotechnology; Capstone Control™ PEEK Spinal System…Nanovis, LLC20240—
+3K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+3K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+3K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+3K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+3K193359SureMAX Family of Cervical SpacersAdditive Implants, Inc.202014—
+4K261810Vertiwedge® Intraosseous SystemFoundation Surgical Group20260—
+4K241487Interwedge® Standalone LateralFoundation Surgical Group, Inc.20241—
+4K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+4K230607SPICCA Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+4K223418DeGen Impulse AM™ SystemDegen Medical20236—
+4K223231Ti-Largo Cervical Interbody SystemFlospine20230—
+4K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+4K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+4K202666CONSTRUX Mini PTC Spacer SystemOrthofix, Inc.202010—
+5K261809Interwedge® Standalone LateralFoundation Surgical Group20260—
+5K253260ORIO-3D Cage SystemSpineCraft20260—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+5K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+5K211704CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer…Orthofix, Inc.20215—
+6K250769Dakota LP SystemPrecision Spine, Inc.20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+6K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K240830Reef TO/TA System; Regatta Lateral System; Explorer TO System; WaveForm C Interbody…Orthofix Medical, Inc.20242—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—