510(k) Report

Devices descending from K092162

49 later devices reach 4CIS Peek, Plif and Tlif Cage System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K1905634CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage…Solco Biomedical Co., Ltd.20192—
+1K120464Innesis Peek CageBk Meditech, Co., Ltd.20136—
+1K121567Oracle Lumbar Intervertebral Body Fusion Cage SystemAccel Spine20125—
+1K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201236—
+1K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd.201237—
+1K110783Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd.201138—
+2K243973FIX-L PEEK PLIF and T-PLIF SystemJeil Medical Corporation20250—
+2K2136534CIS Black Marlin Plif Cage System, 4CIS Dolphin Tlif Cage SystemSolco Biomedical Company India Private Limited20220—
+2K213441PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20222—
+2K212389Advantage Lumbar System - ALIF, PLIF, DLIF, TLIFIntelivation, LLC20210—
+2K192863MONDRIAN Lumbar Interbody Fusion Cage SystemCtl Medical Corporation20203—
+2K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20195—
+2K181963ostaPek Interbody Fusion CagesColigne AG20181—
+2K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201529—
+2K140577Innesis Peek TL CageBk Meditech, Co., Ltd.20142—
+2K123607Octane Elevate Spinal Implant SystemExactech, Inc.20141—
+2K132483Innesis Peek Cervical CageBk Meditech, Co., Ltd.20140—
+3K251741PathLoc Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.20250—
+3K242829BluEX Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20240—
+3K230478Acro Composites Interbody SystemAcro Composites, LLC20230—
+3K231680AccelFix Lumbar Expandable Cage SystemL&K BIOMED Co., Ltd.20231—
+3K220513NITRO Interbody Fusion Cage System FamilyCtl Medical Corporation20230—
+3K213641MONDRIAN ALIF Cage with Supplementary Fixation PlateCtl Medical Corporation20221—
+3K220953ChoiceSpine TigerShark™ M, Modular Interbody SystemChoice Spine, LLC20220—
+3K203531XYPAN Expandable Lumbar Cage SystemAegis Spine, Inc.20213—
+3K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd.20196—
+3K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd.201810—
+3K172756Varian cageMedyssey USA, Inc.20171—
+3K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC20178—
+4K231715MONDRIAN™ Anterior Lumbar Plate SystemCtl Medical Corporation20240—
+4K231241NanoHive Medical Lumbar Interbody SystemNanoHive Medical, LLC20230—
+4K221719ABTross ALIF Expandable Cage SystemAegis Spine, Inc.20222—
+4K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd.20224—
+4K201793EDEN Peek CageJmt Co., Ltd.20210—
+4K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd.20215—
+4K203327VERTACONNECT TLIF CageSignus Medizintechnik20210—
+4K182406Altus Spine Interbody Fusion SystemAltus Partners, LLC20191—
+4K170553Altus Spine Interbody Fusion SystemAltus Partners, LLC20170—
+4K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20172—
+4K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC20176—
+5K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd.20233—
+5K223474PathLoc-TA Expandable Lumbar Cage SystemL&K BIOMED Co., Ltd.20231—
+5K211837Altus Spine Interbody Standalone Fusion SystemAltus Partners, LLC20220—
+5K181829Velofix TLIF CageU&I Corporation20181—
+5K172253Altus Spine Cervical Interbody Fusion SystemAltus Partners, LLC20170—
+6K232822Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…Gbs Commonwealth Co., Ltd.20232—
+6K183243Velofix TLIF CageU&I Corporation20190—
+7K233839Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…Gbs Commonwealth Co., Ltd.20231—
+8K243915FIX-C 3D Ti ACIF SystemJeil Medical Corporation20250—