510(k) Report

Devices descending from K951657

438 later devices reach VSP (Variable Screw Placement) Spinal Fixation System, Pedicle Screw (S)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+9K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+9K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+9K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+9K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+9K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+9K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+9K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+9K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+10K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+10K262094E3D™-C Interbody SystemEvolution Spine20260—
+10K260286Dynamo™ Spinal Cement; Salvo® Spine SystemSpine Wave, Inc.20260—
+10K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+10K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+10K260038E3D™-C Interbody SystemEvolution Spine20261—
+10K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+10K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+10K252437JAZZ Spinal SystemImplanet20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+10K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+10K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+10K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+11K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+11K182470Plateau Spacer SystemLife Spine20180—
+12K222362Salvo® Spine SystemSpine Wave, Inc.20223—