510(k) Report

Devices descending from K031780

1,326 later devices reach Verte-Stack Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K220025ARx® Spinal SystemLife Spine, Inc.20220—
+11K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+11K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+11K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+11K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+11K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+11K191575ARx Spinal SystemLife Spine, Inc.201910—
+11K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+11K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+11K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+12K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+12K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+12K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+12K233256Robotic Integration InstrumentsDePuy Synthes20240—
+12K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+12K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+12K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+12K200070ARx Spinal SystemLife Spine, Inc.20209—
+13K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+13K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+13K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+13K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+13K210549ARx Spinal SystemLife Spine, Inc.20211—
+13K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+14K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+14K230880CoreLink Navigation InstrumentsCorelink, LLC20230—