510(k) Report

Devices descending from K983706

19 later devices reach Modification of Townley Pedicle Screw Plating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031354Ebi OMEGA21 Spinal Fixation SystemEbi, L.P.200313—
+1K031355Ebi Spinelink - II Spinal Fixation SystemEbi, L.P.20034—
+2K082353Mercury Spinal SystemSpinal Elements, Inc.200911—
+2K083230Mercury Spinal SystemSpinal Elements, Inc.200811—
+2K042772Ebi Array Spinal Fixation System and Spinelink II Spinal Fixation DeviceEbi, L.P.20043—
+3K222516Mercury® II Spinal SystemSpinal Elements, Inc.20223—
+3K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc.20195—
+3K172967Mercury® Spinal SystemSpinal Elements, Inc.20185—
+3K151215Mercury Spinal SystemSpinal Elements, Inc.20158—
+3K141372Mercury Spinal SystemSpinal Elements, Inc.20149—
+3K091587Mercury Spinal SystemSpinal Elements, Inc.200910—
+3K070530Modification to Passmed Spinal SystemMedicrea Technologies20072—
+4K243916Primus Spinal Fixation SystemSpinal Elements, Inc.20252—
+4K193472OrthoCircle Spine Pedicle Screw SystemOrthocircle Spine20200—
+4K190981NEX-D2 Posterior Fixation SystemNext Orthosurgical20200—
+4K190376PASS LP Spinal SystemMedicrea International SA201915
+5K251154RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation InstrumentsHt Medical D.B.A. Xenix Medical20251—
+5K213281PASS LP™ Spinal System, CD Horizon™ Spinal SystemMedicrea International SA20220—
+6K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor…Xenix Medical20260—