510(k) Report

Devices descending from K091813

719 later devices reach Intrepid Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+10K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+10K211306LabyrinthZavation Medical Products, LLC20213—
+10K201453Fortilink Cages with TiPlus TechnologyParadigm Spine GmbH20204—
+11K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+11K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+11K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+11K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+11K230026SqualeImplanet, S.A.20230—
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+12K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—