510(k) Report

Devices descending from K032303

14 later devices reach Stryker Consolidated Operating Room Equipment (Core) System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071859Stryker Crossfire SystemStryker Endoscopy200742
+1K040369Stryker Consolidated Operating Room Equipment (Core) SystemStryker Instruments200478
+1K040300Stryker Consolidated Operating Room Equipment (Core)Stryker Instruments200478
+2K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC20250—
+2K162770Relign SystemRelign Corporation20172—
+2K132264PRIMADO2 Total Surgical SystemNakanishi, Inc.20136—
+3K241008Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Handpiece…Relign Corporation, Subsidiary of Zimmer Biomet20240—
+3K233638VERZA™ High Speed DrillsGlobus Medical, Inc.20241—
+3K233493Tricera Arthroscopic System; Tricera Controller (R-10001); Tricera Shaver Handpiece…Relign Corporation20231—
+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—