510(k) Report

Devices descending from K080722

8 later devices reach Primado Surgical Drill through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083112PrimadoNakanishi, Inc.20097—
+2K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbH20221—
+3K202120P300 AttachmentNakanishi, Inc.20211—
+4K252662UniBurNakanishi, Inc.20250—
+4K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.20240—
+4K240568DuraPro™ Oscillating SystemGlobus Medical, Inc.20240—