510(k) Report

Devices descending from K200846

4 later devices reach Balteum™ Lumbar Plate System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222572FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and…Dio Medical Corporation20222—
+1K213820BALTEUM - ONE™ Lumbar Plate SystemHuvexel Co., Ltd.20223—
+2K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+2K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—