510(k) Report

Devices descending from K202475

3 later devices reach PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211869OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA)…Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE20220—
+1K210607PALACOS R pro, PALACOS R+G pro, PALACOS MV+G proHeraeus Medical GmbH202116
+2K213812PALACOS MV proHeraeus Medical GmbH202202