510(k) Report

Devices descending from K955807

15 later devices reach Cotrel-Dubousset (CD) Spinal through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031595U & I America Spinal Hook SystemU&I Corp., America2003143
+2K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+2K113324Rexious Hook Fixation SystemsDio Medical Co., Ltd.20126—
+2K101374Aaxter A3 Posterior Spinal SystemAaxter Co., Ltd.20110—
+3K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+3K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+3K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine201322
+3K131522Core Pedicle Screw SystemCore-Nexus20130—
+4K241657MSFX Mikron Spinal Fixation SystemMikron Makina Sanayi VE Ticaret Ltd. Sti.20243—
+4K232586Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal SystemK&J Consulting Corp.20230—
+4K173185SEURAT™ Universal Pedicle Screw SystemCtl Medical Corporation20180—
+4K140219Picasso II Mis Spinal SystemAccel Spine20141—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—