510(k) Report

Devices descending from K991031

878 later devices reach Colorado II Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+8K191489Genesys Spine 3DP Cervical Interbody SystemGenesys Spine20207—
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+8K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+8K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+8K182470Plateau Spacer SystemLife Spine20180—
+8K181883FIREFLY® Midline Navigation GuideMighty Oak Medical, Inc.20184—
+8K181399FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20185—
+8K172194Connector SystemOrthofix, Inc.2017162
+8K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+8K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+8K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+8K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+8K133369Tiger Spine SystemCorelink, LLC201429—
+9K261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLC20260—
+9K262094E3D™-C Interbody SystemEvolution Spine20260—
+9K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.20260—
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K253472FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical20260—
+9K260038E3D™-C Interbody SystemEvolution Spine20261—
+9K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+9K252894aprevo® cervical interbody systemCarlsmed, Inc.20261—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K250637VCFix Spinal SystemAmber Implants20250—
+9K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+9K242899NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20240—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+9K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC20241—
+9K232628VADER® Pedicle SystemIcotec AG20241—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K233594Genesys Spine 3DP AIS-C II Cervical Interbody SystemGenesys Spine20232—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20233—
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+9K230731Zavation ALIF SystemZavation Medical Products, LLC20232—
+9K230766Altus Spine Monaco Pedicle Screw SystemAltus Spine20231—
+9K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+9K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+9K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+9K211417F3D-C2 Cervical Stand-Alone SystemCorelink, LLC20223—
+9K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+9K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+9K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+9K193219G Surgical Marksman SystemG Surgical, LLC20191—
+9K190751Connector SystemOrthofix, Inc.20193—
+9K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+9K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+10K250769Dakota LP SystemPrecision Spine, Inc.20250—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251735Stabilis SA Cervical Stand-Alone System (Various PNs)Acuity Surgical Devices, LLC20251—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K242483Genesys Spine AIS-C II Cervical Interbody Fusion SystemGenesys Spine20250—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+10K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc.20242—
+10K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+10K240685Salvo® Spine SystemSpine Wave, Inc.20242—
+10K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+10K230329F3D Interbody SystemCorelink, LLC20230—
+10K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+10K203452Nano FortiFix® SystemNanovis, LLC20200—
+11K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+11K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+11K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+11K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+11K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI)20251—
+12K261451ZSAlign Cervical Interbody SystemZSFab, Inc.20260—