510(k) Report

Devices descending from K151422

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200303Reform Pedicle Screw SystemPrecision Spine202010—
+1K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+2K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+2K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+2K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+2K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+2K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+2K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+2K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+2K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+3K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+3K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+3K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+3K233256Robotic Integration InstrumentsDePuy Synthes20240—
+3K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+4K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+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—