510(k) Report

Devices descending from K202458

6 later devices reach BonOs Inject, Pedicle screw kits, Cement pusher through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+2K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+2K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+3K243693NEO Pedicle Screw System™Neo Medical SA20240—
+3K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+4K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—