510(k) Report

Devices descending from K091725

150 later devices reach Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182544AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.201910—
+1K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd.2011123—
+1K100956Spondy Spinal Fixation SystemAllure Spine LLC201017—
+1K100575LDR Spine Usa Spine Tune TL Spine SystemLdr Spine USA20107—
+2K261130AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20260—
+2K232311LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20231—
+2K231636LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20232—
+2K230245LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20233—
+2K223565LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation…L&K BIOMED Co., Ltd.20224—
+2K200789LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal SystemL&K BIOMED Co., Ltd.20200—
+2K200794AccelFix Spinal Fixation SystemL&K BIOMED Co., Ltd.20208—
+2K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.20164—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)2013752
+2K121568Dali Spinal Fixation SystemAccel Spine20121—
+2K120714Picasso Mis Spinal Fixation SystemAccel Spine20122—
+2K120760LDR Spine Spinetune TL Spinal SystemLdr Spine USA, Inc.20124—
+2K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd.2012111—
+2K112643Focus Mis SystemL&K BIOMED Co., Ltd.201226—
+2K111115Captiva Spine Caplox II Spinal Fixation SystemCaptiva Spine, Inc.201116—
+2K102331LDR Spine Usa Spinetune TL Spinal SystemLdr Spine USA20106—
+3K243281LOCK-IN Spinal Fixation SystemLock-In USA Corp20240—
+3K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+3K200790LnK Spinal Fixation System, OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.20205—
+3K173645JASPER Spinal Fixation SystemGbs Commonwealth Co., Ltd.20183—
+3K173180Mega Plus Spine SystemBk Meditech, Co., Ltd.20183—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC20162—
+3K143110GALAXY MIS Screw SystemBm Korea20152—
+3K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd.201533—
+3K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+3K140123Polaris Spinal System -Translation ScrewEbi, LLC2014221
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2014671
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)201370—
+3K122332Towerlox Pedicle Screw SystemCaptiva Spine201214—
+3K120292Caplox II Pedicle Screw SystemCaptiva Spine, Inc.2012151
+3K120140Focus Spinal SystemL&K BIOMED Co., Ltd.201225—
+4K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+4K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—
+4K201788EDEN Spinal Fixation SystemJmt Co., Ltd.20221—
+4K210275Polaris Spinal SystemZimmer Biomet Spine, Inc.20210—
+4K201420Republic Spine Dark Star Spinal SystemRepublic Spine, LLC20212—
+4K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201—
+4K190762The JASPER Spinal Fixation System IIGbs Commonwealth Co., Ltd.20191—
+4K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+4K182059Prase MIS Spinal SystemGbs Commonwealth Co., Ltd.20182—
+4K180433Ennovate®Aesculap Implant Systems, LLC201811
+4K171813OpenLoc-L Spinal Fixation System, LnK Spinal Fixation SystemL&K BIOMED Co., Ltd.201730—
+4K162576FORTEZZA Spinal Stabilization SystemOsso Surgical20160—
+4K161766PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.201618—
+4K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20165—
+4K151974Polaris Spinal SystemBiomet Spine201516—
+4K150896Vitality Spinal Fixation SystemZimmer Spine, Inc.2015193
+4K151422Reform Pedicle Screw SystemPrecision Spine, Inc.201519—
+4K143248Reform Pedicle Screw SystemPrecision Spine, Inc.201430—
+4K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+4K131538Caplox II Pedicle Screw System/Towerlox Pedicle Screw SystemCaptiva Spine20136—
+5K230325GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal SystemGreens Surgicals Pvt., Ltd.20240—
+5K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+5K240392JAZZ Spinal SystemImplanet20241—
+5K232292Peridot-EX Expandable Intervertebral Body Fusion SystemGbs Commonwealth Co., Ltd.20230—
+5K230961Zeus Spinal SystemShanghai Sanyou Medical Co, Ltd.20232—
+5K231931Adena-Zina Spinal SystemShanghai Sanyou Medical Co, Ltd.20230—
+5K230762EDEN Spinal Fixation MIS SystemJmt Co., Ltd.20230—
+5K223096Dark Star Deformity Pedicle Screw SystemRepublic Spine, LLC20231—
+5K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+5K210963ENNOVATE Spinal SystemAesculap Implant Systems, LLC20210—
+5K200981Mega Plus MIS Spine SystemBk Meditech, Co., Ltd.20200—
+5K200303Reform Pedicle Screw SystemPrecision Spine202010—
+5K191655MEGAFIX® Pedicle Screw Spinal SystemSeohancare Co., Ltd.20200—
+5K193396PERLA® TL posterior osteosynthesis systemSpineart202072
+5K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+5K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems201913—
+5K182974NuVasive Reline SystemNu Vasive, Incorporated201911—
+5K183168OpenLoc-L Spinal Fixation SystemL&K BIOMED Co., Ltd.201823—
+5K183117PathLoc-L MIS Spinal SystemL&K BIOMED Co., Ltd.20184—
+5K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+5K172101ROMEO® 2 Posterior Osteosynthesis SystemSpineart20179—
+5K170861PremierShandong Weigao Orthopaedic Device Co., Ltd.20170—
+5K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+5K150856Reform Pedicle Screw SystemPrecision Spine, Inc.201526—
+5K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+6K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.20260—
+6K253966PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20260—
+6K242827A8 INTEGR8™ Porous Pedicle ScrewsAllumin8, Inc.20251—
+6K252437JAZZ Spinal SystemImplanet20250—
+6K242297Reform Pedicle Screw SystemPrecision Spine, Inc.20240—
+6K242764MediRod Pedicle Screw SystemCmf Medicon Surgical, Inc.20240—
+6K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda20230—
+6K231069PERLA® TL Posterior Thoraco-lumbar Fixation SystemSpineart SA20231—
+6K220862E-GPS Navigated InstrumentsPrecision Spine, Inc.20227—
+6K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems202212—
+6K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+6K220025ARx® Spinal SystemLife Spine, Inc.20220—
+6K213470PERLA® TL Posterior Osteosynthesis SystemSpineart20222—
+6K203506PERLA® TL posterior osteosynthesis systemSpineart202132
+6K203222PERLA TL Posterior Osteosynthesis SystemSpineart20204—
+6K191575ARx Spinal SystemLife Spine, Inc.201910—
+6K172105The Plateau-LO Spacer SystemLife Spine, Inc.20181—
+6K173814DeGen Medical E3 MIS Pedicle Screw SystemDegen Medical20180—