510(k) Report

Devices descending from K032560

787 later devices reach Arrowhead Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K233366SYMPHONY OCT SystemMedos International SARL20230—
+8K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+8K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+8K231199Solar Lumbar Interbody Fusion SystemDegen Medical20235—
+8K230989Rod Registration FrameNu Vasive, Incorporated20230—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223837SPIRA®-C Integrated Fixation SystemCamber Spine Technologies20230—
+8K223413Pisces™-SA STANDALONE ALIF Interbody SystemOsseus Fusion Systems20233—
+8K222789VADER® Pedicle System, G21 CementIcotec AG202352
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222107Black Diamond™ POCT Spinal SystemOsseus Fusion Systems20220—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K220888MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement GuidesMedacta International S.A.20221—
+8K203023Pisces Spinal SystemOrtho Development Corporation20210—
+8K203319SYMPHONY™ OCT SystemMedos International SARL20211—
+8K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+8K192930Dymaxeon Spine SystemBack 2 Basics Direct, LLC20201—
+8K193129Yukon OCT Spinal SystemK2m, Inc.202001
+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—
+9K254105Hive™ Standalone Cervical System and Hive™ C Interbody SystemNanoHive Medical, LLC20260—
+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—
+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—
+9K232628VADER® Pedicle SystemIcotec AG20241—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+9K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+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—
+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—
+10K260385aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and…Carlsmed, Inc.20260—
+10K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+10K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+10K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+10K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+10K243461Calibrate Interbody SystemsAlphatec Spine, Inc.20250—
+10K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+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—
+10K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+10K203452Nano FortiFix® SystemNanovis, LLC20200—
+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—