510(k) Report

Devices descending from K031914

1,530 later devices reach Spinal Concepts, Inc. Cadence and Fortitude through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+11K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+11K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+11K201006K2M Navigation InstrumentsK2m, Inc.20200—
+11K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K191575ARx Spinal SystemLife Spine, Inc.201910—
+11K171425Concorde LiftMedos International SARL201782
+12K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+12K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+12K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+12K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+12K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+12K220025ARx® Spinal SystemLife Spine, Inc.20220—
+12K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+12K200070ARx Spinal SystemLife Spine, Inc.20209—
+12K182349Concorde LiftMedos International SARL20190—
+12K173537Concorde Lift™Medos International SARL20181—
+13K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+13K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+13K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+13K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+13K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+13K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+13K210549ARx Spinal SystemLife Spine, Inc.20211—
+13K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+14K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—