510(k) Report

Devices descending from K072339

534 later devices reach Nuvasive Anterior Lumbar Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241564Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISBaxter Healthcare Corporation20240—
+8K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+8K241019aprevo® TLIF-C Articulating SystemCarlsmed20244—
+8K241212MagnetOs Easypack PuttyKuros Biosciences20241—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System…SeaSpine Orthopedics Corporation20243—
+8K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+8K240699SCARLET® AC-TiSpineart SA20240—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+8K232282aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal…Carlsmed, Inc.20240—
+8K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+8K240453ReBOSSISOrthorebirth Co., Ltd.202402
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+8K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+8K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+8K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+8K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+8K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+8K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+8K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+8K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+8K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+8K230936Anatomic PEEK™ Cervical Fusion System with NanotechnologyNanovis, LLC20230—
+8K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+8K231140aprevo® transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20236—
+8K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K221324ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)Camber Spine Technologies20230—
+8K223326Axiom PSR SystemRestor3D202301
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+8K213417Ghost Spacer SystemLife Spine, Inc.20220—
+8K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+8K222561AlignAcuity Surgical Devices, LLC202214—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K221535Align Lumbar Interbody Fusion SystemAcuity Surgical Devices, LLC20223—
+8K220610SOLO-LAurora Spine, Inc.20220—
+8K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+8K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+8K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+8K210542aprevo Transforaminal IBFCarlsmed, Inc.202112—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+8K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+8K201287Impulse Interbody Fusion SystemDegen Medical20208—
+8K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K201614TxTiHA IBF System, AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.2020471
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+8K192054Endoskeleton TAS PlateTitan Spine, Inc.20190—
+8K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+9K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+9K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…INNO Holdings Inc. DBA Innovasis20260—
+9K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+9K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+9K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K260549ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemZsfab, Inc.20260—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K252742Navigated InstrumentsTyber Medical, LLC20251—
+9K252322SIros-X SystemGenesys Spine20250—
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—