510(k) Report

Devices descending from K922322

242 later devices reach Alphatec 3.5MM Znnulated Cortical Lag Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K202266Reliance Cervical IBF SystemReliance Medical Systems, LLC20223—
+7K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+7K212853Cervical Stand-Alone SystemEminent Spine, LLC202118—
+7K212562Idys-C ZP 3DTiClariance, SA20211—
+7K211646FINE OsteotomyBodycad Laboratories, Inc.20213—
+7K203129NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) SystemPrecision Spine, Inc.20210—
+7K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC202025—
+7K190870Cervical Spinal Truss System-Stand Alone (CSTS-SA)4Web, Inc.201910—
+7K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC201993—
+7K173102Reliance Cervical IBF SystemReliance Medical Systems, LLC201715—
+7K171075Calix-C Cervical Interbody SpacerX-Spine Systems, Inc.201715—
+7K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20175—
+7K152622Alta ACDF SystemBiomet Spine20160—
+7K142269Reliance Cervical IBF SystemReliance Medical Systems, LLC201523—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K242303MOD-COrthomod, LLC20260—
+8K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc.20244—
+8K232348RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion SystemMiRus, LLC20231—
+8K231739Cervical Spine Truss System (CSTS)4Web Medical, Inc.20232—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K230329F3D Interbody SystemCorelink, LLC20230—
+8K231314Fine Osteotomy™Bodycad Laboratories, Inc.20232—
+8K223362Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device4Web Medical, Inc.20233—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+8K222903Tailored-H Cervical Stand Alone SystemBespoke Technologies, LLC20220—
+8K221162UniVy OsteoVy Cervical IBF SystemVy Spine, LLC20222—
+8K212527Cervical Spine Truss System Plating Solution (CSTS-PS)4Web Medical, Inc.20220—
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K212715Vy Spine ClariVy Cervical IBF SystemVy Spine, LLC20216—
+8K203520Blustone Synergy Interbody Fusion SystemBlustone Synergy, LLC20210—
+8K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+8K193000Hexanium® ACIFSpinevision, S.A.S.202014—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+8K193153SPIRA-C Integrated Fixation SystemCamber Spine Technologies20202—
+8K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC202072—
+8K173832InTice™-C Porous Ti Cervical Interbody SystemX-Spine Systems, Inc.201801
+8K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+8K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+9K253894BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o.20260—
+9K252240Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage SystemSpectrum Spine20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+9K253200Cervical Spine Truss System - Stand Alone (CSTS-SA)4Web Medical, Inc.20250—
+9K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.20250—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K243074Spectrum Spine Lumbar Cage SystemSpectrum Spine, Inc.20252—
+9K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+9K233807LumiVy™ Lumbar IBF SystemVy Spine, LLC20241—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K233966Anterior Spine Truss System-Stand Alone (ASTS-SA)4Web Medical, Inc.20241—
+9K240066Fine Osteotomy™Bodycad Laboratories, Inc.20241—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+9K230026SqualeImplanet, S.A.20230—
+9K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K221578Hexanium ACIFSpinevision, S.A.S.20224—
+9K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+9K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+9K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+9K171657ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.20174—
+10K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+10K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+10K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K240703Fine Osteotomy™Bodycad Laboratories, Inc.20240—
+10K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+10K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+10K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+10K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+10K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+10K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+10K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+11K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+11K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+11K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+11K250769Dakota LP SystemPrecision Spine, Inc.20250—
+11K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K232432E3D™-A Interbody SystemEvolution Spine20248—
+11K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+11K221172FOCUS Interbody SystemOc Medical Devices20220—
+11K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+11K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+11K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+12K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+12K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—
+12K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—