510(k) Report

Devices descending from K181606

3 later devices reach Precision Spine Navigation Instrumentation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252962DYNAMIS™ Navigation SystemPromethean Restorative, LLC20260—
+1K240963Spinal SystemTeslake, Inc.20240—
+1K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—