510(k) Report

Devices descending from K082797

209 later devices reach Blackstone Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K190376PASS LP Spinal SystemMedicrea International SA201915
+7K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+7K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+7K231694MASADA Modular Spinal Fixation SystemAstura Medical20232—
+7K233366SYMPHONY OCT SystemMedos International SARL20230—
+7K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+7K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—