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
+3K122571Malibu Spinal System with the Daytona Deformity SystemSeaspine, Inc.201262—
+3K122226Revere Stabilization SystemGlobus Medical, Inc.2012225—
+3K121568Dali Spinal Fixation SystemAccel Spine20121—
+3K121630Range Spinal SystemK2m, Inc.2012127—
+3K121250OP Spine SystemOrthoPediatrics Corp.201218—
+3K120829Stainless Steel Spinal SystemTheken Spine, LLC20120—
+3K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+3K111448Icon (TM) Modular Pedicle Screw SystemOrthofix, Inc.20120—
+3K113755Savannah Technologies Spinal SystemSavannah Technologies, LLC20120—
+3K110896Reliance Spinal Screw SystemReliance Medical Systems, LLC20125—
+3K103573ARTS2 Spinal Fixation SystemAdvanced Medical Technologies20110—
+3K112920Range Spinal System (Mesa and Denali)K2m, Inc.201149—
+3K112551S4 Spinal SystemAesculap Implant System, Inc.201161—
+3K110497Pass LP Spinal SystemMedicrea International20111331
+3K111301Instinct Java SystemZimmer Spine201131
+3K110906Apex Spine SystemSpinecraft, LLC2011103—
+3K110280Revlok Fenestrated Screw SystemGlobus Medical, Inc.201195—
+3K110321Tiger Spine SystemCorelink, LLC201183—
+3K110216Expedium System, Viper SystemDepuy Spine, Inc.20114—
+3K103133Veper System, Expedium SystemDepuy Spine, Inc.20110—
+3K102249Expedium Spine SystemDepuy Spine, A Johnson & Johnson Company2010218—
+3K102488Apex Spine System W/ Cocr RodsSpinecraft, LLC2010177—
+3K101112Reliance Spinal Screw SystemReliance Medical Systems20107—
+3K102701Viper Spine SystemDepuy Spine, Inc.2010184—
+3K093926Firebird Spinal Fixation SystemBlackstone Medical, Inc.201088—
+3K092825Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw WasherSpinecraft, Inc.2010178—
+3K092473Expedium Spine SystemDepuy Spine, Inc.2009263—
+3K092626Modification to: Expedium Spine SystemDepuy Spine, Inc.20090—
+3K083567Gii Spinal Fixation System, Gii-TI-Poly Axial ScrewCo-Ligne AG20091—
+3K070385TI-Tamed Spinal SystemTi-Tamed (Pty), Ltd.20090—
+3K091110Spinal Edge Titan Pedicle Screw SystemSpinal Edge, LLC20091—
+3K090648Viper 2 SystemDepuy Spine, Inc.2009337—
+3K091253Thoracolumbar Plate, Model 1208-41FXX, Lumber Plate, Model 1208-41FXXL, Sacral Plate…K2m, Inc.200973—
+3K081978Reliance Spinal Screw SystemReliance Medical Systems, LLC20098—
+3K090230Expedium Spine SystemDepuy Spine, Inc.2009462—
+3K081153Novel Spinal SystemMedyssey Co, Ltd.200923—
+3K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+3K083743Capsure PS SystemSpine Wave, Inc.20093—
+3K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+3K082942Modfication to: Expedium Spine SystemDepuy Spine, Inc.2008518—
+3K081883Modification to Preference Pedicle Screw SystemUs Spine20082—
+3K081898Expedium Spine SystemDepuy Spine, Inc.200859—
+3K082195Modifications to Expedium Spine SystemDepuy Spine, Inc.2008269—
+3K073562Modification to Viper Spine SystemDepuy Spine, Inc.2008213—
+3K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008397—
+3K073430Valeo Pedicle Screw Spinal SystemAmedica Corp.200824—
+3K072605Malibu Spinal SystemSeaspine, Inc.200767—
+3K071921Innovasis Excella Spinal System, Excella-M (Monoaxial Screws), Excella-P (Polyaxial…Innovasis, Inc.20075—
+3K071890Zodiac 4.0 Polyaxial Spinal Fixation SystemAlphatec Spine, Inc.20071801
+3K072081Zodiac Dynamo Semi-Rigid Spinal SystemAlphatec Spine, Inc.20071—
+3K070387Expedium Spine SystemDepuy Spine, Inc.2007248—
+3K063772Expedium Spine SystemDepuy Spine, Inc.2007264—
+3K063668Roc Lumbar SystemAlphatec Spine, Inc.20070—
+3K070245Capsure Pedicle Screw SystemSpine Wave, Inc.200742—
+3K062912Scient'x Spinal SystemScient'X200736—
+3K063741Expedium Spine SystemDepuy Spine, Inc.2007398—
+3K061774Nfix II Pedicle Screw SystemN Spine, Inc.200627
+3K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006424—
+3K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc.2006131—
+3K051089Gii Spinal Fixation SystemCo-Ligne AG20054—
+3K051063Polyaxial Hemispherical Spinal ScrewsScient'X200537—
+3K040747Aladyn Rigid Spine PlateScient'X20040—
+3K033150Art Posterior Spinal SystemAdvanced Medical Technologies AG20041—
+3K033352Vertebron PSS Pedicle Screw SystemVertebron, Inc.200462—
+3K020245Modification to Isobar Spinal SystemScien'Tx USA, Inc.200243—
+3K991326Isobar Semi-Rigid Spinal SystemScien'Tx USA, Inc.19992—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+4K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+4K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+4K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+4K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+4K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+4K250908Virata Spinal Fixation SystemSeaSpine Orthopedics Corporation202521
+4K250602X-PAC® N-GAGE™ Lumbar Plate SystemExpanding Innovations, Inc.20250—
+4K242516EUROPA™ Posterior Cervical Fusion SystemMiRus, LLC20242—
+4K242361OZARK Cervical Plate System; PYRENEES® Cervical Plate System; EVEREST® Spinal System…Stryker Spine20241—
+4K243106CarboClear® Hybrid Pedicle Screw SystemCarboFix Orthopedics, Ltd.20240—
+4K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+4K233793CarboClear® X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20241—
+4K241276Vector™ Pedicle Screw SystemInnovasis, Inc.202411
+4K240872Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation SystemClariance20241—
+4K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+4K234048M.U.S.T. Pedicle Screw System - ExtensionMedacta International S.A.20241—
+4K233694Meridian Interbody System; WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20248—
+4K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsCarboFix Orthopedics, Ltd.20243—
+4K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+4K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+4K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+4K232341CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.20234—
+4K230880CoreLink Navigation InstrumentsCorelink, LLC20230—
+4K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+4K223181NuVasive Reline SystemNu Vasive, Incorporated202311—
+4K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+4K223273ASTRA Spine SystemSpinecraft, LLC20228—
+4K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+4K222732WaveForm A Interbody SystemSeaSpine Orthopedics Corporation20229—
+4K211027Altus Spine Pedicle Screw SystemAltus Partners, LLC20222—
+4K222110Mariner RDX SystemSeaSpine Orthopedics Corporation202282
+4K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+4K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—