510(k) Report

Devices descending from K002607

339 later devices reach Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments…CarboFix Orthopedics, Ltd.20242—
+8K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+8K231658VEOS Spinal Fixation SystemSpineway20230—
+8K230026SqualeImplanet, S.A.20230—
+8K223273ASTRA Spine SystemSpinecraft, LLC20228—
+8K222614Zavation Spinal SystemZavation Medical Products, LLC20223—
+8K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+8K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+8K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+8K211113Zavation Spinal SystemZavation Medical Products, LLC20214—
+8K210874Reliance Spinal Screw SystemReliance Medical Systems, LLC20212—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.202061—
+8K202327Invictus™ OsseoScrew® SystemAlphatec Spine, Inc.20200—
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K190751Connector SystemOrthofix, Inc.20193—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+9K260340HC Biologics Osteopoint Peek Cages, HC Biologics Osteopoint Cervical Peek Cages, HC…HC Biologics, LLC20260—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K252686EffortMed PEEK Cages & Corpectomy CagesEffortmed, LLC20251—
+9K252088Firebird SI Navigation SystemOrthofix US, LLC20251—
+9K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+9K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+9K243908Tiger 2 SystemZavation Medical Products, LLC20251—
+9K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+9K233256Robotic Integration InstrumentsDePuy Synthes20240—
+9K213750VyLink™ Spinal Screw SystemVy Spine, LLC20221—
+9K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+9K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+10K253943Tiger 2 SystemZavation Medical Products, LLC20260—
+10K260850Osteomni Spinal Cages SystemOsteomni, Inc.20260—
+10K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+10K233366SYMPHONY OCT SystemMedos International SARL20230—
+11K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—