510(k) Report

Devices descending from K150322

4 later devices reach InterV Kyphoplasty Catheter (Balloon Length: 10,15 and 20mm) InterV… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231340Renova Spine Balloon CatheterBiopsybell S.R.L.20230—
+1K172871SpineKure Kyphoplasty SystemHanchang Co., Ltd.20180—
+1K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)Pan Medical, Ltd.20161—
+2K211797TRACKER Plus Kyphoplasty SystemGS Medical Co., Ltd.20210—