510(k) Report

Devices descending from K011437

325 later devices reach Synergy 4.0 MM, 4.5 MM VLS Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+7K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+7K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+7K203452Nano FortiFix® SystemNanovis, LLC20200—
+7K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+7K190751Connector SystemOrthofix, Inc.20193—
+7K190376PASS LP Spinal SystemMedicrea International SA201915
+7K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+8K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+8K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+8K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+8K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+8K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+8K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+8K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+8K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+9K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+9K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+9K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+9K233366SYMPHONY OCT SystemMedos International SARL20230—
+9K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+10K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—