510(k) Report

Devices descending from K133614

527 later devices reach Aleutian Ibf System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+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—
+7K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+7K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K230026SqualeImplanet, S.A.20230—
+7K222554EL CAPITAN Anterior Lumbar Interbody FusionAstura Medical20235—
+7K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+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—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—