510(k) Report

Devices descending from K091301

473 later devices reach Life Spine Stand-Alone Spacer System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K240699SCARLET® AC-TiSpineart SA20240—
+9K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+9K233951CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)Medtronic Sofamor Danek USA, Inc.20245—
+9K240424Mineral Collagen Composite Bioactive Moldable Bone Graft MatrixCollagen Matrix, Inc.20240—
+9K240453ReBOSSISOrthorebirth Co., Ltd.202402
+9K234013Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20243—
+9K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+9K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+9K233414Shoreline ACS Interbody System; Shoreline RT Interbody SystemSeaSpine Orthopedics Corporation20238—
+9K231076VariLift®-C Interbody Fusion SystemWenzel Spine, Inc.20234—
+9K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+9K230414ClariVy™ Cervical IBF SystemVy Spine, LLC20233—
+9K223418DeGen Impulse AM™ SystemDegen Medical20236—
+9K220296Manta Ray TDF SpacerSeaSpine Orthopedics Corporation20231—
+9K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+9K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC20225—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K222383Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth (TM)…Medtronic Sofamor Danek USA, Inc.20220—
+9K220523restor3d TiDAL Lumbar Interbody Fusion DeviceRestor3D20222—
+9K220581Zavation eZspand Interbody SystemZavation Medical Products, LLC20224—
+9K221180Anteralign (TM) Spinal System with Titan NanoLOCK Surface Technology Navigated InstrumentsMedtronic Sofamor Danek USA, Inc.20222—
+9K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+9K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+9K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+9K210470C-CURVE Interbody Fusion DeviceMedicrea International SA20210—
+9K210583SeaSpine WaveForm™ A Interbody SystemSeaSpine Orthopedics Corporation202114—
+9K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K203342CONSTRUX Mini Ti Spacer SystemOrthofix, Inc.202191
+9K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+9K202637F3D Corpectomy SystemCorelink, LLC20201—
+9K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+9K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+9K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+9K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+9K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+9K191581Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion…Titan Spine, Inc.202081—
+9K191565Endoskeleton TCS Interbody Fusion DeviceTitan Spine, Inc.201901
+9K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+10K263172SAS MIS Pelvic Incidence RodsSpinal Alignment Solutions, Inc.20260—
+10K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.20260—
+10K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K252742Navigated InstrumentsTyber Medical, LLC20251—
+10K252322SIros-X SystemGenesys Spine20250—
+10K251522Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™Bone Solutions, Inc.20251—
+10K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+10K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+10K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—
+10K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+10K243007CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20243—
+10K242372Mg OSTEOREVIVE™, Mg OSTEOCRETE™Bone Solutions, Inc.20242—
+10K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+10K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+10K234087restor3d TIDAL Lumbar Interbody Fusion SystemRestor3D20240—
+10K231836ClariVy™ Cervical IBF SystemVy Spine, LLC20232—
+10K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+10K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+10K223326Axiom PSR SystemRestor3D202301
+10K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+10K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+10K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+10K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+10K212811Ti3Z Lumbar Interbody SystemZavation Medical Products, LLC20223—
+10K203003Pantheon IBFDPantheon Spinal20210—
+11K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+11K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+11K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+11K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+11K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+12K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+12K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+13K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—