510(k) Report

Devices descending from K133286

460 later devices reach Midline (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+7K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+7K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+7K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+7K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+7K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+7K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+7K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+7K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+7K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+7K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+7K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+7K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+8K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K252742Navigated InstrumentsTyber Medical, LLC20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+8K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+8K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+8K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+8K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+8K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+8K223326Axiom PSR SystemRestor3D202301
+8K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+8K203003Pantheon IBFDPantheon Spinal20210—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+9K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—