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
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K181390Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine SystemOrthoPediatrics Corp.201813—
+4K181435ATEC Cervical Spacer SystemAlphatec Spine, Inc.2018100—
+4K171832Range/Denali/Mesa Spinal SystemK2m, Inc.201713—
+4K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+4K161842Overwatch Spine SystemAmendia, Inc.201661
+4K162143FixxSure® X-LinkInnovasis, Inc.20160—
+4K161028K2M Growing Spine SystemK2m, Inc.20163—
+4K161369EVEREST Spinal SystemK2m, Incorporated20169—
+4K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+4K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+4K160466Response 5.5 Spine SystemOrthoPediatrics Corp.20161—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K141873Range/Mesa/Denali Spinal SystemK2m, Inc.201430—
+4K140765Range/Mesa/Denali Spinal SystemK2m, Inc.201415—
+4K141147Range Spinal SystemK2m, Inc.20141—
+4K133944Range, Spinal System, Everest Spinal SystemK2m, Inc.201433—
+4K132757Everest Spinal SystemK2m, Inc.201341—
+4K131784Range Spinal SystemK2m, Inc.201334—
+4K130932Firebird Spinal Fixation SystemOrthofix, Inc.2013811
+4K122877Range Spinal System, Small StatureK2m, Inc.201334—
+4K130330Range Spinal SystemK2m, Inc.201336—
+4K123552Instinct Java SystemZimmer Spine201301
+4K123412Range Spinal System, Small Strature ComponentsK2m, Inc.201334—
+4K122592Instinct Java SystemZimmer Spine201301
+4K113270Instinct Java SystemZimmer Spine201121
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K253545Vulcan Spinal SystemK2m, Inc.20260—
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K240326Solar™ Lumbar Interbody Fusion SystemDegen Medical, Inc.20244—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K222105RESPONSE 5.5/6.0 Cannulated Screw SystemOrthoPediatrics Corp.20230—
+5K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+5K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+5K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K211805IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec…Alphatec Spine, Inc.202138—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K210539CoreLink Midline Fixation SystemCorelink, LLC20214—
+5K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc.201999—
+5K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+5K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.20182—
+5K181119Range (Denali and Mesa) Spinal SystemsK2m, Inc.20185—
+5K181188EVEREST Spinal SystemK2m, Inc.20186—
+5K180376K2M Patient Specific RodsK2m, Inc.20182—
+5K173508Everest Spinal SystemK2m20189—
+5K171321K2M Navigation InstrumentsK2m201711
+5K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+5K160208NILE Alternative Fixation Spinal SystemK2m, Inc.20165—
+5K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+5K153031RANGE/DENALI/MESA Spinal SystemK2m, Incorporated20152—
+5K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+5K150325Range/Denali/Mesa Spinal SystemK2m, Inc.201512—
+5K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+5K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+5K133402K2M Modular HooksK2m, Inc.20140—
+5K140529Everest Spinal SystemK2m, LLC201431—
+5K132361Everest Spinal SystemK2m, Inc.201334—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+6K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+6K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+6K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—