510(k) Report

Devices descending from K082342

716 later devices reach Modification to Capstone Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+10K230026SqualeImplanet, S.A.20230—
+10K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+10K211306LabyrinthZavation Medical Products, LLC20213—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+11K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+11K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+12K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—