510(k) Report

Devices descending from K973854

831 later devices reach Orion Anterior Cervical Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+11K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+11K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+11K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+11K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+11K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+11K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+11K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+11K221182Southern Transforaminal Lumbar Interbody Fusion (TLIF)Southern Medical (Pty), Ltd.20220—
+11K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+11K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+11K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+11K212075ShurFit Lumbar Interbody SystemPrecision Spine, Inc.20211—
+11K212070KMTI S141 Lumbar Interbody Fusion SystemKyocera Medical Technologies, Inc.20210—
+11K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+11K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+11K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+12K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+12K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+12K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+12K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+12K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+12K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+12K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+12K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+12K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+12K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+12K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+13K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+13K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—