510(k) Report

Devices descending from K143163

636 later devices reach AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+7K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+7K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+7K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+7K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+7K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+7K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+7K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+7K211306LabyrinthZavation Medical Products, LLC20213—
+7K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+8K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—