510(k) Report

Devices descending from K043566

726 later devices reach Modification to Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+10K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+11K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+11K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+11K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+11K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+11K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+11K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+11K230026SqualeImplanet, S.A.20230—
+11K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+11K211306LabyrinthZavation Medical Products, LLC20213—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+12K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+12K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+13K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—