510(k) Report

Devices descending from K992168

547 later devices reach Moss Miami 6.35MM Polyaxial Screw through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC20192—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K160003Sniper (R) Spine SystemSpine Wave, Inc.20167—
+7K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+7K151216Everest Spinal SystemK2m, Inc.201511—
+7K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+7K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+7K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+8K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+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—
+8K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+8K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+8K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+8K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+8K233256Robotic Integration InstrumentsDePuy Synthes20240—
+8K240392JAZZ Spinal SystemImplanet20241—
+8K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+8K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+8K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+8K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+8K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+8K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+8K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+8K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+8K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+8K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+9K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+9K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+9K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+9K252437JAZZ Spinal SystemImplanet20250—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+9K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+9K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+9K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+10K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+10K182470Plateau Spacer SystemLife Spine20180—
+11K222362Salvo® Spine SystemSpine Wave, Inc.20223—