510(k) Report

Devices descending from K132264

6 later devices reach PRIMADO2 Total Surgical System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+1K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+1K202120P300 AttachmentNakanishi, Inc.20211—
+2K252662UniBurNakanishi, Inc.20250—
+2K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.20240—
+2K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—