510(k) Report

Devices descending from K093669

744 later devices reach Sec Ibf Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+10K231743F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro…Corelink, LLC20233—
+10K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+10K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+10K221578Hexanium ACIFSpinevision, S.A.S.20224—
+10K221646CD HORIZON™ ASTUTE™ SPINAL SYSTEM; CD HORIZON™ Growth Rod Conversion Set; CD HORIZON™…Medtronic Sofamor Danek USA, Inc.202220—
+10K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+10K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+10K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+10K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+10K211111SureMAX-SA Cervical Standalone SystemAdditive Implants, Inc.20218—
+10K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+10K201287Impulse Interbody Fusion SystemDegen Medical20208—
+10K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+10K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+10K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+10K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+10K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+10K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+10K192718Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D TechnologyPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.20195—
+10K192047Rampart™ One Lumbar Interbody Fusion SystemSpineology, Inc.20190—
+11K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+11K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+11K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+11K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+11K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K223418DeGen Impulse AM™ SystemDegen Medical20236—
+11K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+11K212358Romero Cervical CageSpineup, Inc.20226—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K211306LabyrinthZavation Medical Products, LLC20213—
+12K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+12K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+12K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+12K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+12K230026SqualeImplanet, S.A.20230—
+13K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+13K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—