510(k) Report

Devices descending from K132505

645 later devices reach Acculif TL and PL Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K212358Romero Cervical CageSpineup, Inc.20226—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+10K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K230026SqualeImplanet, S.A.20230—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—