510(k) Report

Devices descending from K080411

764 later devices reach Plateau Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+9K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+9K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+9K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K243671ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20240—
+9K242350Spinal Alignment Solutions Pelvic Incidence (PI) Rod SystemSpinal Alignment Solutions, Inc.20241—
+9K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+9K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+9K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+9K240623Omnia Medical TiBrid™-SA SystemOmnia Medical, LLC20240—
+9K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+9K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+9K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+9K230608SPICCA Stand-Alone Cervical Fusion CagesSouthern Medical (Pty), Ltd.20230—
+9K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+9K223105Tesera-K SC SystemKyocera Medical Technologies, Inc.20225—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K212358Romero Cervical CageSpineup, Inc.20226—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K212967AxTiHA Stand-Alone ALIF SystemInnovasis, Inc.20211—
+9K210497SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu…SeaSpine Orthopedics Corporation202139—
+9K211306LabyrinthZavation Medical Products, LLC20213—
+9K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+9K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+9K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+9K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+9K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+9K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+10K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+10K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+10K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+10K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+10K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+10K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+10K250076Endeavor™ Stand-Alone Cervical IBF SystemInnovasis20250—
+10K242928Tesera-k SC SystemKyocera Medical Technologies, Inc.20250—
+10K250603AxTiHA® Stand-Alone ALIF SystemInnovasis20250—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+10K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+10K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+10K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+10K230026SqualeImplanet, S.A.20230—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+11K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—