510(k) Report

Devices descending from K033517

1,528 later devices reach Spinal Concepts Inc. Cadence and Traxis through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+10K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+10K201006K2M Navigation InstrumentsK2m, Inc.20200—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+10K191575ARx Spinal SystemLife Spine, Inc.201910—
+10K171425Concorde LiftMedos International SARL201782
+11K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+11K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+11K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+11K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+11K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+11K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+11K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+11K220025ARx® Spinal SystemLife Spine, Inc.20220—
+11K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+11K200070ARx Spinal SystemLife Spine, Inc.20209—
+11K182349Concorde LiftMedos International SARL20190—
+11K173537Concorde Lift™Medos International SARL20181—
+12K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+12K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+12K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+12K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+12K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+12K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+12K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+12K210549ARx Spinal SystemLife Spine, Inc.20211—
+12K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+13K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—