510(k) Report

Devices descending from K102701

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+5K252542LEO Spinal SystemZheJiang Decans Medical Devices Co., Ltd.20260—
+5K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.20260—
+5K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+5K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody…Curiteva, Inc.20260—
+5K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+5K253331PressON Spinal Fixation SystemNexus Spine20250—
+5K252737DeGen Medical Latitude-C AM Cervical Interbody Fusion SystemDegen Medical20250—
+5K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+5K241077DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20242—
+5K241082INNOVERSE Navigation InstrumentsInnosys Co., Ltd.20240—
+5K240126ProAM ALIF SystemPro Surgical, Inc.20242—
+5K232628VADER® Pedicle SystemIcotec AG20241—
+5K233443Vital™ Navigation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)20230—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+5K213654NuVasive Reline Cervical SystemNu Vasive, Incorporated20221—
+5K213720Vital Navigation SystemZimvie (Zimmer Biomet Spine, Inc.)20220—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+5K211993Z-LINKPC SystemZavation Medical Products, LLC20210—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+5K193219G Surgical Marksman SystemG Surgical, LLC20191—
+5K190636NuVasive® Reline® 4.5-5.0 SystemNu Vasive, Incorporated201913—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191553NuVaisve® Reline® Cervical SystemNu Vasive, Incorporated20192—
+5K190360LineSider™ Spinal SystemIntegrity Implants, Inc.201913—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K182470Plateau Spacer SystemLife Spine20180—
+5K180226TREND II Spinal Fixation System- STEP SeriesPaonan Biotech Co., Ltd.20181—
+5K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+5K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+5K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+6K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K250520OsteoCentric Navigated Instruments SystemOsteocentric Technologies, Inc.20250—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K251644ProAM ALIF SystemPro Surgical, Inc.20250—
+6K243419Altus Spine Navigation SystemAltus Partners, LLC20250—
+6K250667DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20251—
+6K242517ProAM ACDF SystemPro Surgical, Inc.20240—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+6K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+6K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+6K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+6K221388NuVasive Reline Cervical SystemNu Vasive, Incorporated20220—
+6K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+6K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+6K203452Nano FortiFix® SystemNanovis, LLC20200—
+6K203367LineSider™ Spinal SystemIntegrity Implants, Inc.202054
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K162750Libra Pedicle Screw SystemSpinal Balance, Inc.20160—
+7K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+7K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+7K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+7K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine20250—
+7K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+7K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+7K232650KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20236—
+7K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—
+7K220025ARx® Spinal SystemLife Spine, Inc.20220—
+7K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+7K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K253093Vital™ Spinal Fixation SystemHighridge Medical, LLC20250—
+8K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+8K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+8K210549ARx Spinal SystemLife Spine, Inc.20211—
+8K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+9K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—