510(k) Report

Devices descending from K123027

709 later devices reach Capstone (R) Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+8K230026SqualeImplanet, S.A.20230—
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K211306LabyrinthZavation Medical Products, LLC20213—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+9K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—