510(k) Report

Devices descending from K190881

4 later devices reach Spinal Elements Navigated Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+2K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+3K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+4K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—