510(k) Report

Devices descending from K090460

8 later devices reach Bonos Inject through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202458BonOs Inject, Pedicle screw kits, Cement pusherOsartis GmbH20216—
+1K121876Vertecem II Cement KitAap Biomaterials GmbH20120—
+2K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+3K230774PERLA® TL System; TEKTONA® HV US Bone CementSpineart20230—
+3K222256BonOs® Inject Bone Cement; NEO Pedicle Screw System™Neo Medical SA20223—
+4K243693NEO Pedicle Screw System™Neo Medical SA20240—
+4K231809Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS…Ulrich Medical USA20231—
+5K251719Momentum® Posterior Spinal Fixation SystemUlrich Medical USA, Inc.20250—