510(k) Report

Devices descending from K021705

330 later devices reach Modification to Townley Transfacepedicular Screw Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+8K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K232318VICTORY™ Lumbar Plate SystemGlobus Medical, Inc.20230—
+8K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K231841PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20231—
+8K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K223521ZESPIN SI Joint Fusion SystemAegis Spine, Inc.20232—
+8K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc.20233—
+8K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+9K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251131Annex® 2 Adjacent Level SystemSpine Wave, Inc.20250—
+9K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+9K240201PathLoc SI Joint Fusion SystemL&K BIOMED Co., Ltd.20240—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—