510(k) Report

Devices descending from K081395

854 later devices reach Solitaire Peek-Optima Anterior Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K241464ARx® SAI Implant SystemLife Spine, Inc.20241—
+8K240721ExcelsiusFlex™Globus Medical, Inc.20240—
+8K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…Icotec AG20240—
+8K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG20240—
+8K231850QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® InstrumentsGlobus Medical, Inc.20242—
+8K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+8K223869ChoiceSpine Blackhawk Ti Cervical Spacer SystemChoice Spine, LLC20232—
+8K231252Ventana™ L Spinal SystemSpinal Elements, Inc.20231—
+8K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+8K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc.20224—
+8K213951FORZA XP Expandable Spacer SystemOrthofix US, LLC20224—
+8K211449Triton™ Sacroiliac Joint Fixation SystemChoice Spine, LLC20211—
+8K211388Lateral Spine Truss System (LSTS) Interbody Fusion Device4Web Medical, Inc.20210—
+8K201024Expandable Titanium PLIF/TLIF SystemSpectrum Spine, LLC20215—
+8K203576FORZA Ti Spacer SystemOrthofix, Inc.202161
+8K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+8K203153CREO Stabilization System, Navigation Instruments, ExcelsiusGPSGlobus Medical, Inc.20211—
+8K201643ChoiceSpine Tiger Shark Cervical Spacer SystemChoice Spine, LLC20204—
+8K202198FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc.20202—
+8K201646Shoreline ACS (Anterior Cervical System)SeaSpine Orthopedics Corporation202020—
+8K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc.20201—
+8K200685RIGEL 3DR Anterior Cervical Interbody Fusion SystemMiRus, LLC20200—
+8K200312Tryptik TiSpineart20202—
+8K1803473d CageFims Co., Ltd.20190—
+8K192214CarboClear VBR SystemCarboFix Orthopedics, Ltd.20191—
+8K191339Zavation eZspand Interbody SystemZavation Medical Products, LLC20195—
+8K190291Addivation Medical Cervical Interbody SystemAddivation Medical, LLC20190—
+8K183243Velofix TLIF CageU&I Corporation20190—
+8K190889Republic Spine Restore Cervical Interbody Fusion SystemRepublic Spine, LLC20190—
+8K183588Choice Spine Hawkeye Vertebral Body Replacement (VBR) SystemChoicespine20195—
+8K182114FlareHawk Interbody Fusion SystemIntegrity Implants, Inc.20196—
+8K182584Lucent® XPSpinal Elements, Inc.20183—
+8K181921Solidity Vertebral Body ReplacementUlrich Medical USA20182—
+8K181829Velofix TLIF CageU&I Corporation20181—
+8K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc.201898—
+8K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+8K173159Cervical Spinal Truss System (CSTS) Interbody Fusion Device4Web, Inc.201812—
+8K153105MLX™ - Medial Lateral Expandable Lumbar Interbody SystemNu Vasive, Incorporated2016234—
+9K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.20260—
+9K261205SPINEART Navigation Instrument SystemSpineart SA20260—
+9K253802KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20261—
+9K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5…Globus Medical, Inc.20260—
+9K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—
+9K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG20251—
+9K243188Cylox® STSignus Medizintechnik GmbH20250—
+9K243739AxCess® Expandable Interbody SystemElliquence, LLC20250—
+9K232996Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF)Shanghai Iatrical-Ti Technologies CO, Ltd.20240—
+9K234150Lucent® XPSpinal Elements20240—
+9K221266Cervical Spine Truss System (CSTS) Interbody Fusion Device4Web Medical, Inc.20233—
+9K211785CASSATT™ SIJ Fixation SystemCtl Medical Corporation20220—
+9K202298Lucent XP, Lucent XP CurvedSpinal Elements, Inc.20202—
+10K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O20260—
+10K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw…CarboFix Orthopedics, Ltd.20260—