510(k) Report

Devices descending from K150856

26 later devices reach Reform Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+1K200303Reform Pedicle Screw SystemPrecision Spine202010—
+1K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+2K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+2K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+2K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+2K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+3K233256Robotic Integration InstrumentsDePuy Synthes20240—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+3K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+3K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+4K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+5K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—