510(k) Report

Devices descending from K100945

463 later devices reach Fuse Plif Cafe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K202495SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC20216—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K192006SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC202014—
+6K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+6K183092Kuros TLIF CageKuros Biosciences B.V20190—
+7K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+7K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+7K250769Dakota LP SystemPrecision Spine, Inc.20250—
+7K252742Navigated InstrumentsTyber Medical, LLC20251—
+7K252322SIros-X SystemGenesys Spine20250—
+7K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+7K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+7K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+7K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+7K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+7K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+7K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+7K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+7K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+7K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+7K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+7K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+7K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+7K212358Romero Cervical CageSpineup, Inc.20226—
+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—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K230026SqualeImplanet, S.A.20230—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—