510(k) Report

Devices descending from P970015

1,426 later devices reach Inter Fix Threaded Fusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K171321K2M Navigation InstrumentsK2m201711
+8K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+9K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+9K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+9K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K213196MARVEL™ Growing RodsGlobus Medical, Inc.20220—
+9K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+9K220025ARx® Spinal SystemLife Spine, Inc.20220—
+9K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+9K201006K2M Navigation InstrumentsK2m, Inc.20200—
+9K200070ARx Spinal SystemLife Spine, Inc.20209—
+10K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+10K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+10K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+10K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+10K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+10K210549ARx Spinal SystemLife Spine, Inc.20211—
+10K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+11K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—