510(k) Report

Devices descending from K161842

6 later devices reach Overwatch Spine System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+2K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+2K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—