510(k) Report

Devices descending from K153603

79 later devices reach Alphatec Navigation Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223808Zavation Navigation Instrument SystemZavation Medical Products, LLC20230—
+1K182731Corelink Navigation InstrumentsCorelink, LLC20195—
+1K181606Precision Spine Navigation InstrumentationPrecision Spine, Inc.20193—
+1K172517SeaSpine Navigation SystemSeaSpine Orthopedics Corporation2018601
+1K172623NuVasive Navigation InstrumentsNu Vasive, Incorporated20176—
+2K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+2K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+2K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+2K240963Spinal SystemTeslake, Inc.20240—
+2K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+2K212825CoreLink Navigation InstrumentsCorelink, LLC20214—
+2K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+2K192495Black Diamond Navigation InstrumentsOsseus Fusion Systems20200—
+2K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+2K183630SPINEART Navigation Instrument SystemSpineart SA20196—
+2K180038NuVasive Pulse SystemNu Vasive, Incorporated20183—
+3K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+3K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+3K254158SPINEART Navigation Instrument SystemSpineart SA20261—
+3K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+3K242933SPINEART Navigation Instrument SystemSpineart SA20252—
+3K241644SPINEART Navigation Instrument SystemSpineart SA20243—
+3K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+3K232116CoreLink Navigation InstrumentsCorelink, LLC20230—
+3K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+3K220973CoreLink Navigation InstrumentsCorelink, LLC20221—
+3K214059CoreLink Navigation InstrumentsCorelink, LLC20220—
+3K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+3K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+3K210472SPINEART Navigation Instrument SystemSpineart20215—
+4K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+4K242890SPINEART Navigation Instrument SystemSpineart SA20253—
+4K243814NuVasive Pulse SystemGlobus Medical, Inc.20250—
+4K230989Rod Registration FrameNu Vasive, Incorporated20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+5K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+5K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+5K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+6K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+6K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+6K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+7K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+7K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+7K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+7K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+7K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K252322SIros-X SystemGenesys Spine20250—
+8K250894Eminent Spine Posterior SI SystemEminent Spine20250—
+8K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC20250—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—