510(k) Report

Devices descending from K031595

14 later devices reach U & I America Spinal Hook System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+1K113324Rexious Hook Fixation SystemsDio Medical Co., Ltd.20126—
+1K101374Aaxter A3 Posterior Spinal SystemAaxter Co., Ltd.20110—
+2K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+2K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+2K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine201322
+2K131522Core Pedicle Screw SystemCore-Nexus20130—
+3K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+3K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+3K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+3K140219Picasso II Mis Spinal SystemAccel Spine20141—
+4K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+4K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+5K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—