510(k) Report

Devices descending from K162220

9 later devices reach DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) Cage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212792Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageMedynus, Inc.20210—
+1K212038K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK CageK&J Consulting Corporation20211—
+1K172419Velofix™ TLIF CageU&I Corporation20172—
+1K173080IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF)Huvexel Co., Ltd.20172—
+2K250335IVA & AEON Cervical and Lumbar Cage SystemK&J Consulting20250—
+2K211935ORIO-Ti Intervertebral Body Fusion Cage SystemSpinecraft, LLC20210—
+2K192248Cortina™ [MAX] Lumbar Cage SystemNeurostructures, Inc.20190—
+2K183243Velofix TLIF CageU&I Corporation20190—
+2K181829Velofix TLIF CageU&I Corporation20181—