510(k) Report

Devices descending from K082310

645 later devices reach Hollywood, Pacifica, Redondo, Ventura through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+1K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+1K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+1K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+1K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+1K173022SeaSpine Ventura NanoMetalene SystemSeaSpine Orthopedics Corporation20170—
+1K162206Zavation IBFZavation, LLC201724—
+1K152512Half Dome Posterior Lumbar Interbody SystemAstura Medical201633—
+1K153356Spine Innovation Interbody SystemSpine Innovation, LLC20161—
+1K143572Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance…Osteomed Implantes, Ltda20150—
+1K142488SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria…Seaspine, Inc.2014116—
+1K142594nva, nvp, nvtNvision Biomedical Technologies, LLC20144—
+1K142023Luna Interbody SystemBenvenue Medical, Inc.20145—
+1K133418Integra Expandable Interverebral Body Fusion Device (Ibd) SystemSeaspine, Inc.20145—
+1K131082Interform Interbody Cage SystemNext Orthosurgical2013595—
+1K122639Synthes Syncage Evolution SpacerSynthes (USA) Products, LLC2013143—
+1K103297Redondo-LSeaspine, Inc.2011117—
+1K091406Atlas Spine SpacerAtlas Spine, LLC200961
+2K253266Titanium Interbody SystemSpine Innovation, LLC20260—
+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—
+2K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+2K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+2K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+2K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+2K214047EL CAPITAN Anterior Lumbar Interbody Fusion SystemAstura Medical20223—
+2K211501Advantage-C PEEK Cervical lnterbody Fusion DeviceLntelivation, LLC20211—
+2K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+2K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+2K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+2K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+2K201193SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202018—
+2K192492EL CAPITAN Anterior Lumber Interbody SystemAstura Medical, LLC202010—
+2K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+2K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+2K193645nva, nvp, and nvtNvision Biomedical Technologies, Inc.20203—
+2K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+2K182877HALF DOME Posterior Lumbar Interbody SystemAstura Medical, LLC201921—
+2K183659Omnia Medical Rotary PLIF SystemOmnia Medical, LLC20190—
+2K181899Roccia® PlifSilony Medical GmbH20180—
+2K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+2K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+2K181246Zavation IBF SystemZavation Medical Products, LLC201822—
+2K172947HALF DOME Posterior Lumbar Interbody SystemAstura Medical201822—
+2K172019Brisbane ALIF Device, Gladstone ALIF DeviceSignature Orthopaedics Pty, Ltd.20170—
+2K171046SeaSpine Cambria SystemSeaSpine Orthopedics Corporation201762—
+2K163481HALF DOME Posterior Lumbar Interbody SystemAstura Medical201731—
+2K162351SeaSpine® Vu a•POD™ Prime NanoMetalene® Intervertebral Body Fusion DeviceSeaSpine Orthopedics Corporation201679—
+2K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc.20163—
+2K162715SeaSpine Spacer System- Hollywood NanoMetalene, Hollywood VI NanoMetalene, Ventura…SeaSpine Orthopedics Corporation2016103—
+2K151408LOSPA IS Spinal SystemCorentec Co., Ltd.20151—
+2K150673SYNFIX Evolution Secured Spacer SystemSynthes (USA) Products, LLC2015137—
+2K151184InFill Interbody Fusion DevicesPinnacle Spine Group, LLC20153—
+2K141665NuVasive CoRoent SystemNuvasive, Inc.2015588—
+2K100743Atlas Spine Pivoting SystemAtlas Spine, Inc.20104—
+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—
+3K250773Luna® Ti Interbody Fusion SystemSpinal Elements, Inc.20260—
+3K252711Advantage-C™ Ti3D Cervical Interbody Fusion DeviceIntelivation Technologies20260—
+3K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+3K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+3K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+3K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+3K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+3K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+3K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+3K242457EARP Interbody SystemRetropsoas Technologies, LLC20240—
+3K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+3K2402503D Printed PEEK Interbody SystemNvision Biomedical Technologies, Inc.20240—
+3K240749PILLAR SA Ti Spacer System (82-XXX)Orthofix, Inc.202402
+3K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+3K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+3K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+3K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+3K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+3K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+3K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+3K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+3K223326Axiom PSR SystemRestor3D202301
+3K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+3K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+3K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K212477EARP Interbody SystemNvision Biomedical Technologies, Inc.20221—
+3K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+3K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+3K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+3K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+3K210214NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody SystemNu Vasive, Incorporated20213—
+3K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+3K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+3K201287Impulse Interbody Fusion SystemDegen Medical20208—
+3K200084Zavation IBF SystemZavation Medical Products, LLC20208—
+3K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+3K201585Monterey AL Interbody SystemStryker Corporation202044
+3K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+3K193541NuVasive Cohere Thoracolumbar Interbody SystemNu Vasive, Incorporated2020157—
+3K191354Ti3Z Cervical Interbody SystemZavation Medical Products, LLC201913—
+3K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—