510(k) Report

Devices descending from K121760

723 later devices reach Capstone Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+8K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+8K202305Zavation IBF SystemZavation Medical Products, LLC20209—
+8K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+9K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K230026SqualeImplanet, S.A.20230—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—