510(k) Report

Devices descending from K973836

529 later devices reach Synergy 6.35MM SS Rod with Screws for Anterior Use, Part of the Cross… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+9K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+9K182240PASS LP Spinal SystemMedicrea International SA20182—
+9K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+9K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+9K170061ProMIS™ Fixation SystemPremia Spine, Ltd.20170—
+10K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+10K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+10K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+10K241863Erisma® Lp Spinal Fixation System; Erisma® LP MISClariance20240—
+10K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+10K232719ProMIS Extension Rod SystemPremia Spine, Ltd.20230—
+10K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+10K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+10K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+10K220024ChoiceSpine Navigation SystemChoice Spine, LLC20220—
+10K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+10K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+10K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+10K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+10K190376PASS LP Spinal SystemMedicrea International SA201915
+11K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+11K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+11K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+11K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+12K253943Tiger 2 SystemZavation Medical Products, LLC20260—