510(k) Report

Devices descending from K082732

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K230026SqualeImplanet, S.A.20230—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—