510(k) Report

Devices descending from K102067

337 later devices reach Endoskeleton to through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232014CONDUIT™ ATP InsertersEnztec Limited20230—
+7K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody…Nu Vasive, Incorporated20239—
+7K222015Integral Titanium Cervical InterbodyNvision Biomedical Technologies, Inc.20231—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223326Axiom PSR SystemRestor3D202301
+7K223174X-Pac Expandable LLIF Cage SystemExpanding Innovations, Inc.20233—
+7K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+7K222561AlignAcuity Surgical Devices, LLC202214—
+7K220610SOLO-LAurora Spine, Inc.20220—
+7K202398Ti3Z Cervical Interbody SystemZavation Medical Products, LLC20219—
+7K202637F3D Corpectomy SystemCorelink, LLC20201—
+7K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+7K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG20201—
+7K192145Galileo Vertebral Body Replacement DeviceBright Spine20201—
+7K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K261279DeltaNEC Interbody SystemNexus Spine20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K251003X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC20250—
+8K243949OsteoFlo HydroFiberSurGenTec, LLC20250—
+8K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+8K243673Xenco Medical CancelleX Cervical Interbody SystemXenco Medical, LLC20250—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K230329F3D Interbody SystemCorelink, LLC20230—
+8K221542Galileo Vertebral Body Replacement DeviceBright Spine20230—
+8K221049Zavation VariSync Plate System and VariSync Spacer SystemZavation Medical Products, LLC20226—
+8K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+9K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+9K240699SCARLET® AC-TiSpineart SA20240—
+9K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—