510(k) Report

Devices descending from K940631

559 later devices reach Cross Medical - Synergy (TM) Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+5K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+5K173472MySpine Pedicle Screw Placement Guides – MC and Drill Pilot InstrumentsMedacta International S.A.20185—
+5K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+5K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+5K172275Vitality® Spinal Fixation System, Vitality®+ Power Instrument SystemZimmer Biomet Spine, Inc.20170—
+5K172107Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™…Spineology, Inc.20170—
+5K171438Palisade™ Pedicular Fixation SystemSpineology, Inc.20171—
+5K163096GPC BRAND Posterior, Non cervical Pedicle Screw Spinal SystemGpc Medical Limited20170—
+5K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+5K161369EVEREST Spinal SystemK2m, Incorporated20169—
+5K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A.20166—
+5K153404Zavation Spinal SystemZavation, LLC20161—
+5K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162—
+5K143222FIREFLY Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20158—
+5K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+5K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+5K141850Flospine Pedicle Screw SystemFlospine20140—
+5K123373Nautilus Spinal SystemLife Spine201317—
+5K122901Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation SystemOrthofix2012116—
+5K111953Nautilus Spinal SystemLife Spine20123—
+5K111183Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods)Orthofix, Inc.201122—
+5K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201189—
+5K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+5K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+5K100044Firebird Spinal Fixation System, Firebird Side-Loading BodyBlackstone2010117—
+5K090320Conquest Spinal SystemLife Spine20092—
+5K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K252432Flex-Z™ Cervical CageSpinepoint, LLC20260—
+6K253545Vulcan Spinal SystemK2m, Inc.20260—
+6K260038E3D™-C Interbody SystemEvolution Spine20261—
+6K251780iGPS Navigation InstrumentsSI-BONE, Inc.20250—
+6K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+6K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K243514Salvo® Robotic Navigation InstrumentsSpine Wave, Inc.20250—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+6K233256Robotic Integration InstrumentsDePuy Synthes20240—
+6K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+6K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+6K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+6K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+6K231515MySpine Cervical GuidesMedacta International S.A.20230—
+6K230639Align Cervical Interbody Fusion SystemAcuity Surgical Devices, LLC20232—
+6K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+6K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K222455Calibrate LTX Interbody SystemAlphatec Spine, Inc.20228—
+6K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+6K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+6K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+6K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+6K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+6K212980Tesera-k ALIF SystemKyocera Medical Technologies, Inc.20222—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K210090Impulse AM Interbody Fusion SystemDegen Medical20217—
+6K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+6K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+6K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+6K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc.20212—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+6K210155Duo Expandable Interbody Fusion SystemSpineology, Inc.20210—
+6K201287Impulse Interbody Fusion SystemDegen Medical20208—
+6K202820Australis Anterior Lumbar Cage SystemPrism Surgical Designs Pty, Ltd.20200—
+6K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc.202067—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+6K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+6K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+6K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+6K201500Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar SpacerLife Spine, Inc.20203—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+6K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+6K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc.201978—
+6K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+6K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+6K181188EVEREST Spinal SystemK2m, Inc.20186—
+6K171321K2M Navigation InstrumentsK2m201711
+6K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+6K170647Connector SystemOrthofix, Inc.201718—
+6K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+6K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+6K153323Palisade Pedicular Fixation SystemSpineology, Inc.20167—
+6K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+6K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+6K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+6K140696Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc.20145—
+6K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+6K131833Centurion Poct SystemOrthofix, Inc.20142—