510(k) Report

Devices descending from K895107

139 later devices reach Ace Orthopaedic Washers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K242415TMC Compression Implant SystemTreace Medical Concepts20243—
+7K233256Robotic Integration InstrumentsDePuy Synthes20240—
+7K233228Spine Navigation and Robotic-Assistance DeviceEcential Robotics202421
+7K233017TM Plating SystemTyber Medical, LLC20231—
+7K231923Liberty SI Lateral Implant SystemSpinal Simplicity, LLC20230—
+7K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+7K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+7K222698CUVIS-spineCurexo, Inc.20220—
+7K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.20260—
+8K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K253876HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer)Globus Medical, Inc.20251—
+8K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+8K243658TMC Compression Implant SystemTreace Medical Concepts20242—
+8K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+8K234035COSINE™ SpacerGlobus Medical, Inc.20240—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K234077SPIRA® Anterior Lumbar SpacersCamber Spine Technologies20240—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+10K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+11K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+12K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—