510(k) Report

Devices descending from K993503

176 later devices reach Haider-Ucr Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061342Malibu Spinal SystemSeaspine, Inc.2006801
+1K051942Malibu Spinal SystemSeaspine, Inc.20058111
+1K051663Malibu Spinal SystemSeaspine, Inc.200581—
+1K043232Ucr Spinal SystemSeaspine2004971
+1K032739Ucr Spinal SystemSeaspine2003174—
+1K021623Ucr Spinal System, 5.5MM, 8.0MM Screws & InstrumentsIame, Inc.2002175—
+2K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+2K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+2K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+2K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+2K162143FixxSure® X-LinkInnovasis, Inc.20160—
+2K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+2K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+2K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+2K120047Coral Spinal SystemTheken Spine, LLC201214—
+2K081331Fixxsure Cross LinkSpineworks, LLC200891—
+2K072605Malibu Spinal SystemSeaspine, Inc.200767—
+2K062670Vertiflex Spinal Screw SystemVertiflex (Tm), Incorporated200712—
+2K061321Zodiac Adjustable Bridges, Models 11-20XX,11-25XX,11-30XX,11-35XXAlphatec Spine, Inc.20060—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+3K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+3K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K110692Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201189—
+3K102870Exactech Proliant Polyaxial Pedicle Screw SystemExactech, Inc.20119—
+3K073143Modified Vertiflex Spinal Screw SystemVertiflex, Inc.20080—
+3K073245Extended Vertiflex Spinal Screw SystemVertiflex, Inc.200810—
+4K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+4K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+4K253094iFuse Bedrock Granite Implant SystemSI-BONE, Inc.20250—
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+4K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+4K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+4K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+4K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+4K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+4K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+5K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.20260—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+5K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+5K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+5K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+5K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+5K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+5K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+5K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+5K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+5K232044Invictus Robotic Navigation InstrumentsAlphatec Spine, Inc.20233—
+5K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+5K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+5K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+5K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+5K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+5K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+5K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+5K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+5K200070ARx Spinal SystemLife Spine, Inc.20209—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+5K191575ARx Spinal SystemLife Spine, Inc.201910—
+5K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+5K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+5K131100Streamline TL Spinal SystemPioneer Surgical Technology, Inc.20136—
+5K130286Streamline Mis Spinal Fixation SystemPioneer Surgical Technology, Inc.201371
+6K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+6K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+6K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+6K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+6K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+6K253488iFuse INTRA Ti™ Implant SystemSI-BONE, Inc.20260—
+6K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+6K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+6K243838NEXXT MATRIXX® SI SystemNexxt Spine20250—
+6K243565DYNAMIS™ SI Screw SystemPromethean Restorative, LLC20251—
+6K242364IdentiTi™ II Interbody SystemAlphatec Spine, Inc.20244—
+6K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+6K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+6K240505Eminent Spine SI Screw SystemEminent Spine, LLC20241—
+6K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+6K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+6K231744VyLink™ Spinal Screw SystemVy Spine, LLC20230—
+6K232605Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue®…Lesspine Innovations20230—
+6K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+6K220341ARx Modular Spinal SystemLife Spine, Inc.20221—
+6K210549ARx Spinal SystemLife Spine, Inc.20211—
+6K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+6K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+6K182721Choice Spine Navigation SystemChoicespine, LP20192—