510(k) Report

Devices descending from K924381

580 later devices reach PWB Lumbar Laminar Hooks with Set Screws through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.20240—
+7K240963Spinal SystemTeslake, Inc.20240—
+7K240951Invictus Robotic Navigation InstrumentsAlphatec Spine20242—
+7K240368E3D™-A Interbody SystemEvolution Spine20247—
+7K232566NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System…SeaSpine Orthopedics Corporation202412
+7K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC20240—
+7K240737G Surgical Marksman MIS SystemG Surgical, LLC20240—
+7K233989CarboClear® Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd.20242—
+7K233640Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS…Alphatec Spine, Inc.20245—
+7K232432E3D™-A Interbody SystemEvolution Spine20248—
+7K233508iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.20245—
+7K233455ARx MIS Spinal Screw SystemLife Spine, Inc.20230—
+7K231515MySpine Cervical GuidesMedacta International S.A.20230—
+7K232504Calibrate CCX Interbody SystemAlphatec Spine, Inc.202311
+7K232275Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202311—
+7K232097IdentiTi ALIF Interbody SystemsAlphatec Spine, Inc.202371
+7K231811Zavation Connector SystemZavation Medical Products, LLC20230—
+7K231098LineSider® Spinal SystemIntegrity Implants, Inc.20233—
+7K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+7K231438Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody SystemAlphatec Spine, Inc.20237—
+7K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+7K223513UniVy™ OsteoVy™-Ti Cervical IBF SystemVy Spine, LLC20231—
+7K223611Calibrate LTX Interbody SystemAlphatec Spine, Inc.20237—
+7K223418DeGen Impulse AM™ SystemDegen Medical20236—
+7K221806TruLift Lateral Expandable Spacer System & Lateral Plate SystemLife Spine, Inc.20221—
+7K213417Ghost Spacer SystemLife Spine, Inc.20220—
+7K220195iFuse Bedrock Granite™ Implant SystemSI-BONE, Inc.202232—
+7K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.202216—
+7K212358Romero Cervical CageSpineup, Inc.20226—
+7K212088Integrity Implants Navigated InstrumentsIntegrity Implants, Inc.20210—
+7K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd.20210—
+7K210549ARx Spinal SystemLife Spine, Inc.20211—
+7K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+7K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+7K203163ARx Illiac Spinal Screw SystemLife Spine, Inc.20205—
+7K202587ATEC Lateral Interbody SystemAlphatec Spine, Inc.202039—
+7K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+7K201006K2M Navigation InstrumentsK2m, Inc.20200—
+7K201926CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202010—
+7K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+7K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+7K192800Streamline TL Spinal Fixation SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)20203—
+7K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+7K192396Streamline MIS Spinal Fixation SystemPioneer Surgical Technology, Inc.20190—
+7K190526High V+ Bone Cement, CarboClear® Fenestrated Pedicle ScrewsCarboFix Orthopedics, Ltd.201928—
+7K190361Zavation Spinal SystemZavation Medical Products, LLC20190—
+7K183080Mega Plus Spine SystemBk Meditech, Co., Ltd.20182—
+7K182470Plateau Spacer SystemLife Spine20180—
+7K182239OLYMPIC Posterior Spinal Fixation SystemAstura Medical, LLC20182—
+7K182240PASS LP Spinal SystemMedicrea International SA20182—
+7K181603EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and…K2m, Inc.20185—
+7K172194Connector SystemOrthofix, Inc.2017162
+7K170821ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation SystemChoicespine, LP20170—
+7K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+7K160980Threshold Pedicular Fixation System, Palisade Pedicular Fixation SystemSpineology, Inc.20166—
+7K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2016731
+7K151196Nautilus Spinal SystemLife Spine, Inc.201512—
+7K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc.2015781
+7K143230Palladian Lumbar Pedicle Screw SystemNeurostructures, Inc.20150—
+7K141186Firebird Spinal Fixation SystemOrthofix, Inc.20153—
+7K141282PGS 5.5 MM Cannulated Pedicle ScrewPinnacle Spine Group20141—
+7K141804Polaris Spinal System - HA CoatedBiomet Spine, LLC201421—
+7K133743Baxano Surgical Mis Spinal SystemBaxano Surgical, Inc.20140—
+7K132760Nautilus Spinal SystemLife Spine, Inc.201314—
+7K111502Streamline TL Spinal SystemPioneer Surgical Technology, Inc.201188—
+8K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260—
+8K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—
+8K261284Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation SystemAlphatec Spine, Inc.20260—
+8K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+8K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC20260—
+8K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…SeaSpine Orthopedics Corporation20260—
+8K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+8K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+8K254274ARx® SAI Implant SystemLife Spine, Inc.20260—
+8K260786KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+8K253615Invictus Bands SystemAlphatec Spine, Inc.20260—
+8K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—
+8K252597Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For Use with…Alphatec Spine, Inc.20261—
+8K252834Sacroiliac Joint Truss System (SJTS)4Web Medical20260—
+8K253990KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20262—
+8K252781MSFX Mikron Peek CagesMikron Makina Sanayi VE Tic. Ltd. Sti.20251—
+8K253721KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20252—
+8K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical20250—
+8K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+8K252322SIros-X SystemGenesys Spine20250—
+8K251965Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)Alphatec Spine, Inc.20250—
+8K252113PRADO™ Lumbar Interbody Fusion SystemBethesda Medical Devices20250—
+8K251502TruLift® Lateral Expandable Spacer & Lateral Buttress Plate SystemLife Spine, Inc.20250—
+8K250827aprevo® anterior lumbar interbody fusion device; aprevo® lateral lumbar interbody fusion…Carlsmed, Inc.20252—
+8K251080IdentiTi II Cervical Interbody SystemAlphatec Spine, Inc.20250—
+8K251617X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemExpanding Innovations, Inc.20250—
+8K241783FortiVy™ OsteoVy™ Lumbar IBFVy Spine, LLC20250—
+8K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar…Carlsmed, Inc.20253—
+8K241846E3D™-C Interbody SystemEvolution Spine20246—
+8K241892Cortera™ Spinal Fixation SystemXtant Medical Holdings, Inc.20242—
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K241574iFuse TORQ® Implant SystemSI-BONE, Inc.20244—
+8K240893ARTFX MEDICAL Cervical PEEK CagesArtfx Medical20244—
+8K241519Invictus® Small Stature Spinal Fixation SystemAlphatec Spine, Inc.20242—
+8K232413Fusion Robotic Navigation SystemAlphatec Spine, Inc.20232—