510(k) Report

Devices descending from K173130

21 later devices reach Reform® Midline Cortical Screw System through their predicates, nearest generation first.

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