510(k) Report

Devices descending from K061520

517 later devices reach Viper Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+6K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+6K230565HILINE™ Fixation SystemGlobus Medical, Inc.20230—
+6K223494CD Horizon Spinal SystemMedtronic202317—
+6K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+6K223294SpineJack® Expansion KitStryker Instruments20221—
+6K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+6K221403Cortera Spinal Fixation SystemSurgalign Spine Technologies202232
+6K213460Invictus Spinal Fixation SystemAlphatec Spine, Inc.202117—
+6K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.202159—
+6K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+6K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+6K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+6K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+6K200070ARx Spinal SystemLife Spine, Inc.20209—
+6K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+6K191045Salvo™ Spine SystemSpine Wave, Inc.20195—
+6K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+6K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+6K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+6K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+6K180433Ennovate®Aesculap Implant Systems, LLC201811
+6K180198NuVasive® VuePoint® II OCT SystemNu Vasive, Incorporated20184—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K171894NuVasive® Precept™ Spinal SystemNu Vasive, Incorporated20170—
+6K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+6K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+6K170126NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201739—
+6K160020Captiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20160—
+6K133564Modification to Nautilus Spinal SystemLife Spine, LLC201413—
+7K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+7K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+7K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+7K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+7K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+7K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+7K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+7K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+7K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+7K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+7K253331PressON Spinal Fixation SystemNexus Spine20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+7K250637VCFix Spinal SystemAmber Implants20250—
+7K243945ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20250—
+7K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+7K242042TriALTIS™ Spine SystemMedos International SARL20241—
+7K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC20241—
+7K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+7K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+7K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+7K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+7K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+7K223765ATEC Lateral Navigation InstrumentsAlphatec Spine, Inc.202302
+7K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc.202236—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+7K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+7K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202476Salvo® Spine SystemSpine Wave, Inc.20204—
+7K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+7K191723ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20192—
+7K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+7K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K140457Nautilus Spinal SystemLife Spine, Inc.20143—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+8K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc.20243—
+8K232432E3D™-A Interbody SystemEvolution Spine20248—
+8K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+8K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+8K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+8K222973IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System…Alphatec Spine, Inc.202213—
+8K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine202228—
+8K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+8K222362Salvo® Spine SystemSpine Wave, Inc.20223—
+8K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+8K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+9K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+9K241375IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi…Alphatec Spine20253—
+9K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.20245—
+9K242147Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody SystemAlphatec Spine, Inc.20241—
+9K241846E3D™-C Interbody SystemEvolution Spine20246—
+9K240368E3D™-A Interbody SystemEvolution Spine20247—
+9K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+9K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+9K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+9K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371