510(k) Report

Devices descending from K072791

1,055 later devices reach Oracle Spacer, Opal Spacer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K190483SPIRA Open Matrix ALIF and LLIFCamber Spine Technologies20199—
+7K182477Cervical SpacerAdditive Implants, LLC201915—
+7K180777K2M Expandable Interbody SystemK2m, Inc.20180—
+7K181014Tritanium PL CageStryker Spine2018137—
+7K172489Reliance Cervical IBF SystemReliance Medical Systems, LLC201716—
+7K170399Endoskeleton TO Interbody Fusion Device (IBD)Titan Spine, LLC2017105—
+7K170055CAPRI Corpectomy Cage SystemK2m201711—
+7K163364MOJAVE Expandable Interbody SystemK2m201725—
+7K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc.20165—
+7K162264Cascadia Interbody SystemK2m, Inc.2016169—
+7K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K251117Cervical Spine Truss System (CSTS)4Web Medical20250—
+8K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K234119UniSpace® Stand-Alone C CageInnosys Co., Ltd.20241—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K223671CONDUIT LLIF Straight InsertersEnztec Limited20231—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K202949CONSTRUX Mini PEEK Spacer SystemOrthofix, Inc.20206—
+8K193203MOJAVE Expandable Interbody SystemK2m, Inc.202015—
+8K180665SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage SystemK2m, LLC20189—
+8K172941CASCADIA Interbody SystemK2m201852—
+8K171893Blustone Synergy Lumbar Interbody Fusion System (Basalt, Magma, Obsidian), Blustone…Bluestone Synergy20172—
+8K171704CAPRI Corpectomy Cage SystemK2m201710—
+8K171097MOJAVE Expandable Interbody SystemK2m, Inc.201717—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+9K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+9K211320CAPRI Corpectomy Cage SystemK2m, Inc.20222—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K253545Vulcan Spinal SystemK2m, Inc.20260—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—