510(k) Report

Devices descending from K033352

62 later devices reach Vertebron PSS Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+1K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+1K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+1K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+1K081597Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200822—
+1K073531Accin Pedicle Screw SystemAccelerated Innovation, LLC20080—
+1K071376Modification to Vertebron PSS Pedicle Screw SystemVertebron, Inc.200749—
+1K051716Vertebron PSS Pedicle Screw SystemVertebron, Inc.200556—
+1K043152Vertebron PSS Pedicle Screw SystemVertebron, Inc.200561—
+2K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+2K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+2K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K181339Altus Spine Pedicle Screw SystemAltus Partners, LLC20186—
+2K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+2K120353Synster Pedicle Screw System Synster Plus Pedicle Screw SystemBm Korea Co., Ltd.20123—
+2K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K200322Altus Spine Pedicle Screw SystemAltus Partners, LLC20204—
+3K162160Preference Elite Pedicle Screw SystemAmedica Corporation20161—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K080767Conquest Spinal SystemLife Spine200821—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+4K212185Golden Isles Pedicle Screw SystemIntelivation, LLC20210—
+4K200922Altus Spine HA Pedicle Screw SystemAltus Partners, LLC20213—
+4K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+4K123373Nautilus Spinal SystemLife Spine201317—
+4K111953Nautilus Spinal SystemLife Spine20123—
+4K090320Conquest Spinal SystemLife Spine20092—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+5K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+5K220025ARx® Spinal SystemLife Spine, Inc.20220—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210549ARx Spinal SystemLife Spine, Inc.20211—
+5K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+5K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+5K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+9K254274ARx® SAI Implant SystemLife Spine, Inc.20260—