510(k) Report

Devices descending from K020887

1,622 later devices reach Ebi Ais Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+12K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+12K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+12K191575ARx Spinal SystemLife Spine, Inc.201910—
+13K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+13K243835TiLink-P SI Joint Fusion SystemSurGenTec, LLC20240—
+13K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+13K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+13K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+13K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+13K220025ARx® Spinal SystemLife Spine, Inc.20220—
+13K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+13K200070ARx Spinal SystemLife Spine, Inc.20209—
+14K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+14K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+14K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+14K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+14K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+14K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+14K210549ARx Spinal SystemLife Spine, Inc.20211—
+14K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+15K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—