510(k) Report

Devices descending from K031354

13 later devices reach Ebi OMEGA21 Spinal Fixation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+1K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+2K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+2K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+2K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+2K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+2K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+3K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+3K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+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—