510(k) Report

Devices descending from K002607

339 later devices reach Moss Miami 6.35MM Rod System Monoaxial Screws, Polyaxial Reduction Screws and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated…Medos International SARL20190—
+1K061342Malibu Spinal SystemSeaspine, Inc.2006801
+1K051942Malibu Spinal SystemSeaspine, Inc.20058111
+1K051663Malibu Spinal SystemSeaspine, Inc.200581—
+1K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed2002294—
+2K241663Eminent Spine 3D Titanium Pedicle Screw SystemEminent Spine20250—
+2K193219G Surgical Marksman SystemG Surgical, LLC20191—
+2K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+2K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+2K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+2K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+2K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+2K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+2K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+2K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+2K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151—
+2K133690True Spinal Fussion SystemInnovative Surgical Designs20140—
+2K133103Aversion Pedicle Screw SystemK7, LLC20140—
+2K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140—
+2K130958True Spinal Fixation SystemInnovative Surgical Designs20131—
+2K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+2K123717UcentumUlrich GmbH & Co. KG2013171
+2K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+2K120291OP Spine SystemOrthoPediatrics Corp.2012138—
+2K113361Securis Spinal FixationCumtom Spine20120—
+2K120074Foundation Spinal SystemThe Skeletal Design Partnership, Ltd.20122—
+2K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+2K120047Coral Spinal SystemTheken Spine, LLC201214—
+2K113173Nanovis Spinal SystemNanovis, LLC20122—
+2K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices20110—
+2K111883Smartloc Spinal Fixation SystemA-Spine Asia, Co., Ltd.20112—
+2K111099Issys LP Spinal Fixation SystemCustom Spine, Inc.201111
+2K102853Flamenco Spinal Fixation SystemUlrich GmbH & Co. KG2011221
+2K101278Inertia Pedicle Screw SystemNexxt Spine, LLC2010111—
+2K093833Kapss Spinal SystemRobert Reid, Inc.20100—
+2K100377Diamondback Spinal SystemEminent Spine201029—
+2K070385TI-Tamed Spinal SystemTi-Tamed (Pty), Ltd.20090—
+2K072116Savannah Lumbar Percutaneous Stabilization SystemNeurospine Innovations and Solutions200824—
+2K072605Malibu Spinal SystemSeaspine, Inc.200767—
+2K072866Issys LP Spinal Fixation SystemCustom Spine, Inc.200721
+2K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+2K070295Single Planar Multi Axial (Spma) Pedicle Screw SystemTrinity Orthopedics, LLC20070—
+3K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+3K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+3K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K212692Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation202146—
+3K211606Mariner Deformity SystemSeaSpine Orthopedics Corporation2021471
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K200381Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation20202—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K191932Momentum™ Posterior Spinal Fixation SystemUlrich Medical USA20192—
+3K191648Mariner MIS Pedicle Screw System; SeaSpine Navigation SystemSeaSpine Orthopedics Corporation201949—
+3K183639Mariner Outrigger Revision SystemSeaSpine Orthopedics Corporation20198—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180324Patriot Spinal Fixation SystemValorus Spine20180—
+3K153152Syzygy Stabilization SystemAmendia, Inc.201602
+3K151704Diplomat® Spinal SystemSignus Medizintechnik GmbH20164—
+3K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K132925Savannah-T, Reduction, Savannah-T, High-Top, Savannah-T, Monoaxial Mid-Top, Savannah-T…Amendia, Inc.2014231
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K120891Tangors Multifunctional Posterior SystemUlrich GmbH & Co. KG201218—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K111301Instinct Java SystemZimmer Spine201131
+3K102248Excella II Spinal System Model EC2-00Innovasis, Inc.201043
+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—
+4K251073Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E…Innovasis, Inc.202501
+4K251804KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20254—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+4K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc.202214—
+4K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+4K220025ARx® Spinal SystemLife Spine, Inc.20220—
+4K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+4K200937ACURA Stabilization SystemIndius Medical Technologies Pvt., Ltd.20200—
+4K193100RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine SystemOrthoPediatrics Corp.20204—