510(k) Report

Devices descending from K200303

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+1K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+2K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+2K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+2K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+2K233256Robotic Integration InstrumentsDePuy Synthes20240—
+2K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+3K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+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—