510(k) Report

Devices descending from K950709

541 later devices reach Synergy TI Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+9K203561ChoiceSpine Navigation SystemChoice Spine, LLC20211—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K182598VersaLink™ Fixation SystemPremia Spine, Ltd.20180—
+9K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+9K172115Navigated Instrument SystemOrthofix, Inc.20184—
+9K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc.2017611
+9K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+9K161842Overwatch Spine SystemAmendia, Inc.201661
+9K161694Threshold™ Pedicular Fixation SystemSpineology, Inc.20163—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+10K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+10K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+10K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+10K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+10K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+10K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+10K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+10K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+10K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+10K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+11K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+11K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+11K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+11K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+11K233366SYMPHONY OCT SystemMedos International SARL20230—
+11K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+11K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+11K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+11K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+11K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+11K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+12K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+12K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+12K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+13K253943Tiger 2 SystemZavation Medical Products, LLC20260—