510(k) Report

Devices descending from K002775

719 later devices reach Distal Volar Radius Fracture Repair System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+13K202833Sequel External Fixation DeviceSequel Medical, Inc.20211—
+13K182007Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) SystemRenovis Surgical Technologies20180—
+14K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+14K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+14K262094E3D™-C Interbody SystemEvolution Spine20260—
+14K261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…Kyocera Medical Technologies, Inc.20260—
+14K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+14K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+14K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.20260—
+14K260038E3D™-C Interbody SystemEvolution Spine20261—
+14K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+14K251862External Fixation Bone DistractorParagon 28, Inc.20250—
+14K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+14K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+15K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+15K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+15K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+16K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+17K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—