510(k) Report

Devices descending from K181111

2 later devices reach Navigated INFINITY Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231229S-COMP Reform® POCT Navigation InstrumentsPrecision Spine, Inc.20230—
+1K214059CoreLink Navigation InstrumentsCorelink, LLC20220—