510(k) Report

Devices descending from K063393

493 later devices reach Small Stature Spacers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+8K223335SIRION Lateral Lumbar Interbody SystemAstura Medical20230—
+8K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+8K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+8K222203DualXSLIM (R) T/PLIFAmplify Surgical, Inc.20223—
+8K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+8K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+8K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+8K220453FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20221—
+8K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+8K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+8K212904SeaSpine WaveForm C Interbody SystemSeaSpine Orthopedics Corporation202115—
+8K211740DualXAmplify Surgical, Inc.20211—
+8K211873PSX Interbody SystemAlphatec Spine, Inc.202111—
+8K210382Blustone Synergy Diamond SA Cervical SystemBlustone Synergy, LLC20210—
+8K203003Pantheon IBFDPantheon Spinal20210—
+8K211441Navigated Anterolateral Disc Prep InstrumentsMedtronic Sofamor Danek USA, Inc.20219—
+8K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20215—
+8K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K200719NuVasive Navigation.S InstrumentsNu Vasive, Incorporated20204—
+8K200879SeaSpine Meridian System, SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation202060—
+8K192434DualX Lumbar Intervertebral Body Fusion DeviceAmplify Surgical, Inc.20190—
+8K183249Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved…Stryker Spine20196—
+8K181079SeaSpine Regatta Lateral SystemSeaSpine Orthopedics Corporation201863—
+8K173606SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu…SeaSpine Orthopedics Corporation201859—
+8K173260SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica…SeaSpine Orthopedics Corporation201767—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K261060Navigated LLIF Impactable TrackerTyber Medical, LLC20260—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K250987aprevo® posterior/transforaminal lumbar interbody fusion deviceCarlsmed, Inc.20251—
+9K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+9K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.20251—
+9K243116FlareHawk Interbody Fusion SystemIntegrity Implants Inc. Dba Accelus20250—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K240625CORUS Navigation Access SystemProvidence Medical Technology, Inc.20244—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+9K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+9K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+9K231275Exceed™ Biplanar Expandable Interbody SystemSpine Wave, Inc.20232—
+9K221490Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior…Stryker Spine20231—
+9K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+9K223412LumiVy™ Lumbar IBF SystemVy Spine, LLC20235—
+9K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+9K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+9K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+9K210574NuVasive Pulse SystemNu Vasive, Incorporated202121
+9K201755WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody SystemSeaSpine Orthopedics Corporation202017—
+9K201585Monterey AL Interbody SystemStryker Corporation202044
+9K200613Tritanium® X TL Expandable Curved Posterior Lumbar CageStryker Corporation20205—
+9K193418SeaSpine Skipjack SystemSeaSpine Orthopedics Corporation20204—
+9K192132SeaSpine Beachside SystemSeaSpine Orthopedics Corporation2019591
+9K191621ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer…Choice Spine, LLC20194—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…Stryker Spine20260—
+10K261159Exceed® Biplanar Expandable Interbody SystemSpine Wave, Inc.20260—
+10K260329Ion-C Navigation InstrumentsSurGenTec, LLC20261—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+10K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.20251—
+10K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion InstrumentsSeaSpine Orthopedics Corporation20250—
+10K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+10K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+10K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+10K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+10K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+10K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+10K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+10K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+10K230989Rod Registration FrameNu Vasive, Incorporated20230—
+10K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+10K213420WaveForm L System, WaveForm TO System, WaveForm TA SystemSeaSpine Orthopedics Corporation202211—
+10K212540Explorer TO SystemSeaSpine Orthopedics Corporation20213—
+10K203311ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20213—
+10K193636SeaSpine Reef TH SystemSeaSpine Orthopedics Corporation202056—
+11K262121Ion-L Navigated InstrumentsSurGenTec, LLC20260—
+11K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+11K261279DeltaNEC Interbody SystemNexus Spine20260—
+11K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+11K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+11K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+11K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—