510(k) Report

Devices descending from K994122

251 later devices reach Bone Graft Washer, Model 9090114 - 9090118 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+7K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+7K220096Genesys Spine 3DP Lumbar Interbody SystemGenesys Spine20220—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+7K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K262094E3D™-C Interbody SystemEvolution Spine20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+8K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K230026SqualeImplanet, S.A.20230—
+8K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K230329F3D Interbody SystemCorelink, LLC20230—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—