510(k) Report

Devices descending from K092017

24 later devices reach Pivotec Lumbar Interbody Fusion Device (Lifd) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181702Tranquil-L Interbody SystemNexus Spine, LLC20188—
+1K170297Tranquil Interbody SystemNexus Spine, LLC201715—
+1K122956Fuselox Lumbar Interbody Fusion DeviceCaptiva Spine20122—
+1K100743Atlas Spine Pivoting SystemAtlas Spine, Inc.20104—
+2K243816Testa TP Pivoting Spacer SystemSpine Wave, Inc.20250—
+2K233375Tranquil-L Interbody SystemNexus Spine, LLC20240—
+2K240416Tranquil-C Interbody SystemNexus Spine, LLC20243—
+2K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC20221—
+2K212498Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20227—
+2K181621Stable-C Interbody SystemNexus Spine, LLC20187—
+2K181483Tranquil Interbody SystemNexus Spine, LLC20186—
+2K180990TirboLOX-L Lumbar IBFDCaptiva Spine, Inc.20181—
+2K172419Velofix™ TLIF CageU&I Corporation20172—
+3K241467Stable-C Interbody SystemNexus Spine, LLC20242—
+3K231486Stable-L Standalone Lumbar Interbody SystemNexus Spine, LLC20231—
+3K232530Stable-L Standalone Lumbar Interbody System, Stable-C Interbody SystemNexus Spine, LLC20235—
+3K231763Stable-C Interbody SystemNexus Spine, LLC20236—
+3K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC20230—
+3K200549Lucero Medical Cervical Cage SystemLucero Medical, LLC20200—
+3K183243Velofix TLIF CageU&I Corporation20190—
+3K181829Velofix TLIF CageU&I Corporation20181—
+3K181229TirboLOX-C Cervical IBFDCaptiva Spine, Inc.20180—
+4K261279DeltaNEC Interbody SystemNexus Spine20260—
+4K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC20250—