510(k) Report

Devices descending from K213820

3 later devices reach BALTEUM - ONE™ 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—
+2K250446Frida™ Anterior Cervical Plate SystemSpineup, Inc.20250—
+2K231460FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System…K&J Consulting Corp.20230—