510(k) Report

Devices descending from K954690

6 later devices reach Stryker Oral Max System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070876Stryker Twist DrillsStryker Craniomaxillofacial20070—
+1K062842Twist DrillWalter Lorenz Surgical, Inc.200651
+2K2130722.1 x 255mm Drill, 22mm StopBiomet Micofixation20221—
+2K213208Twist DrillsBiomet Microfixation20210—
+2K170442Cranial Drill Bits and AccessoriesAd-Tech Medical Instrument Corporation201702
+3K2231992.1 x 255mm Drill, 22mm StopBiomet Microfixation20220—