510(k) Report

Devices descending from K060638

13 later devices reach Dynesys Spinal System with HA Coated Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101790Quantum Spinal System, Quantum MisPioneer Surgical Technology201110—
+1K071879Zimmer Dto ImplantZimmer Spine, Inc.200711
+2K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+2K133153Spinefrontier Pedfuse Pedicle Screw SystemSpinefrontier, Inc.20141—
+2K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+2K101704Zimmer Dto Pin Press InstrumentZimmer Spine, Inc.20100—
+3K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+3K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+3K143377PedFuse Pedicle Screw SystemSpinefrontier, Inc.20150—
+3K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+4K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—