510(k) Report

Devices descending from K955348

1,019 later devices reach Titanium Moss Miami Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+2K061342Malibu Spinal SystemSeaspine, Inc.2006801
+2K062136Pass 2 Spinal SystemMedicrea2006146—
+2K051044Arctec Semirigid Plating SystemAltiva Corp.20050—
+2K051942Malibu Spinal SystemSeaspine, Inc.20058111
+2K051663Malibu Spinal SystemSeaspine, Inc.200581—
+2K042143Excella-M Spinal SystemInnovasis, Inc.20046—
+2K032604Gii Spinal Fixation SystemCo-Ligne AG20045—
+2K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed2003410—
+2K024348Monarch Spine SystemDepuyacromed2003578—
+2K023438Modification to Monarch Spine SystemDepuyacromed20024—
+2K0226235.0 MM Diameter Polyaxial Screws (Moss Miami 6.35MM System)Depuyacromed2002294—
+2K021148Monarch Spine System Commercially Pure Titanium Spinal RodDepuyacromed2002496—
+2K013441Isola Polyaxial WasherDepuyacromed2001262—
+2K013444Isobar Spinal SystemScien'Tx USA, Inc.200194—
+2K001080Spine System EvolutionAesculap, Inc.200062—
+2K990118Isobar Spinal SystemScien'Tx USA, Inc.1999250—
+3K260989Varion Thoracolumbar Fixation SystemKyocera Medical Technologies Inc. (KMTI)20260—
+3K252730Fule Spinal Fixation SystemBeijing Fule Science & Technology Development Co., Ltd.20250—
+3K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+3K242900VADER® Pedicle System and VADER®one Pedicle SystemIcotec AG20250—
+3K243249TriALTIS™ Spine SystemMedos International SARL20250—
+3K243259MASADA Modular Spinal Fixation SystemAstura Medical20250—
+3K2316554CIS® Chiron Spinal Fixation SystemSolco Biomedical Co., Ltd.20240—
+3K240233Pitkar Spinal Pedicle Screw SystemS.H.Pitkar Orthotools Pvt., Ltd.20240—
+3K242069Eminent Spine Scoliosis Deformity Pedicle Screw SystemEminent Spine20240—
+3K241258Ingenix Spinal SystemIngenium Spine20240—
+3K231494CoreLink Robotic Navigation InstrumentsCorelink, LLC20230—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+3K231799INERTIA® CONNEXX™ Modular Pedicle Screw SystemNexxt Spine, LLC20230—
+3K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+3K221776NextGen Pedicle Screw SystemCorelink, LLC20222—
+3K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+3K220711SeaSpine Meridian System, SeaSpine Meridian Anterior Plate SystemSeaSpine Orthopedics Corporation202210—
+3K203023Pisces Spinal SystemOrtho Development Corporation20210—
+3K210306GII Spinal Fixation SystemColigne AG20210—
+3K203452Nano FortiFix® SystemNanovis, LLC20200—
+3K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+3K200885Meridian Anterior Plate System, Regatta Lateral Plate SystemSeaSpine Orthopedics Corporation202012—
+3K193211Nano FortiFix® SystemNanovis Spine, LLC20201—
+3K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+3K193219G Surgical Marksman SystemG Surgical, LLC20191—
+3K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+3K180337EUROPA Pedicle Screw SystemMiRus, LLC20196—
+3K182970EUROPA™ Pedicle Screw SystemMiRus, LLC20192—
+3K180754C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemSignature Orthopaedics Pty, Ltd.20180—
+3K180686SeaSpine Daytona Small Stature Spinal SystemSeaSpine Orthopedics Corporation201812—
+3K180458FOCUS Pedicle Screw SystemNvision Biomedical Technologies, LLC20181—
+3K180176SeaSpine NewPort Spinal SystemSeaSpine Orthopedics Corporation20180—
+3K173882SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation2018561
+3K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—
+3K173508Everest Spinal SystemK2m20189—
+3K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+3K170989Dymaxeon Spine SystemBack 2 Basics Direct, LLC20172—
+3K163363SurgTech Thoracolumbosacral (TLS) Posterior Fixation SystemSurgtech, Inc.20170—
+3K162995Ibis® Pedicle Screw SystemOrtho Development Corporation20173—
+3K163604SeaSpine® Daytona® Small Stature Spinal SystemSeaSpine Orthopedics Corporation201712—
+3K170163Erisma® LP Spinal Fixation SystemClariance, Sas20172—
+3K162786PASS LP Spinal SystemMedicrea International SA20176—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K161842Overwatch Spine SystemAmendia, Inc.201661
+3K161535SeaSpine® NewPort™ Spinal SystemSeaSpine Orthopedics Corporation201614—
+3K161516G Surgical Marksman MIS SystemG Surgical, LLC20163—
+3K152920Savannah-T® Pedicle Screw SystemAmendia, Inc.201601
+3K160902Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation201660—
+3K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC201617—
+3K153413PASS LP Spinal SystemMedicrea International SA20160—
+3K153326Erisma-LP Spinal Fixation SystemClariance, Sas201651
+3K153525Seneka II Polyscrew Pedicle Fixation SystemSenecka Spine20160—
+3K151770Libra Pedicle Screw SystemSpinal Balance, Inc.20151—
+3K151648Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle…Altus Partners, LLC20155—
+3K151849Seneka I Polyscrew Pedicle Fixation SystemSenecka Spine20151—
+3K151727Everest Spinal SystemK2m, Inc.201511—
+3K150184Dymaxeon Spine SystemBack 2 Basics Direct, LLC201541
+3K143683APEX-DL Spine SystemSpinecraft, LLC20153—
+3K150600Response 5.5/6.0 Spine SystemOrthoPediatrics Corp.2015163
+3K150417Astra Spine SystemSpinecraft, LLC201521—
+3K150283Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20154—
+3K141222Nautilus Spinal System and Solstice Oct SystemLife Spine, Inc.201513—
+3K142655CB PROT II Posterior Spinal SystemChin Bone Technique Corp20150—
+3K141695Acrosspine Pedicle Screw SystemArthro-Dif20140—
+3K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+3K141291Vertiform Posterior Fixation SystemNext Orthosurgical20142—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K132049Thunderbolt and Lancer Pedicle Screw SystemsChoicespine201482—
+3K141376Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Nexxt Spine, LLC2014106—
+3K140238Excella Iii-D Spinal Deformity SystemInnovasis, Inc.201432
+3K133066Spineselect Polyscrew Pedicle Screw SystemSpineselect, LLC20140—
+3K132603Apex Spine SystemSpinecraft, LLC201325—
+3K132014GSB Global Spinal Balance SystemNuvasive, Inc.201382—
+3K132412Inertia Mis Pedicle Screw SystemNexxt Spine, LLC2013107—
+3K130877Expedium Spine SystemMedos International SARL20138—
+3K130655Response Spine SystemOrthoPediatrics Corp.201317—
+3K130291S4 Spinal SystemAesculap Implant System, Inc.201344—
+3K121979Pass Oct Spinal SystemMedicrea International201314—
+3K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+3K123352S4 Spinal SystemAesculap Implant Systems, Inc.201251—