510(k) Report

Devices descending from K212489

5 later devices reach BonOs Inject Bone Cement; NEO Pedicle Screw System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+1K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+2K243693NEO Pedicle Screw System™Neo Medical SA20240—
+2K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+3K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—