510(k) Report

Devices descending from K073202

644 later devices reach Ardis Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+8K251335Tera Lumbar Interbody Fusion System (Various PNs)Acuity Surgical Devices, LLC20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K242509HAnano InterFuse (R) Modular InterbodyNext Orthosurgical20240—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241413sagAlign Lumbar Cage System (Various PNs)Acuity Surgical Devices, LLC20240—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+8K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+8K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K212358Romero Cervical CageSpineup, Inc.20226—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K230026SqualeImplanet, S.A.20230—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—