510(k) Report

Devices descending from K983904

27 later devices reach Rogozinski Spinal Rod System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132644Lospa IS Pedicle Screw (Monoaxial & Polyaxial), Lospa IS Rod- Straight (Standard), Lospa…Corentec Co., Ltd.20130—
+1K110046Athena Pedicle Screw SystemRoyal Oak Medical Devices20110—
+1K100757Tilock Pedicle Screw SystemGenesys Spine201091
+1K031595U & I America Spinal Hook SystemU&I Corp., America2003143
+2K172469TiLock Modular Spinal SystemGenesys Spine20170—
+2K171838TiLock2 Spinal SystemGenesys Spine20174—
+2K161914Genesys Spine TiLock Cortical Spinal SystemGenesys Spine20161—
+2K152039Genesys Spine TiLock2 Spinal SystemGenesys Spine20157—
+2K123476Mega 5.5 Spine SystemLsk Biopartners, Inc.20135—
+2K113324Rexious Hook Fixation SystemsDio Medical Co., Ltd.20126—
+2K103671Genesys Spine Tilock SystemGenesys Spine20118—
+2K101374Aaxter A3 Posterior Spinal SystemAaxter Co., Ltd.20110—
+3K252322SIros-X SystemGenesys Spine20250—
+3K222415Rexious Spinal Fixation SystemDio Medical Corporation20221—
+3K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+3K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd.20174—
+3K132365Spondylolisthesis Spinal Fixation, Spinal Pedicle FixationAccel Spine201322
+3K131522Core Pedicle Screw SystemCore-Nexus20130—
+4K253169Duet™ Spinal Fixation SystemBox Spine, LLC20261—
+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—
+5K262712Duet™ Spinal Fixation SystemDuet Spine Holdings, LLC20260—
+5K250092HC Biologics Osteopoint Spinal Fixation SystemHC Biologics, LLC20250—
+5K243946EffortMed Spinal Fixation SystemEffortmed, LLC20251—
+6K254247Osteomni Spinal Fixation SystemOsteomni, Inc.20260—