510(k) Report

Devices descending from K081597

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132280Altus Spine Pedicle Screw SystemAltus Partners20136—
+1K131810Osseus Black Diamond Pedicle Screw SystemOsseus Fusion Systems, LLC201314—
+2K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+2K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+2K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+3K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+3K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+3K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+4K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+4K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+4K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+4K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+4K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+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—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—