Cleared Special

RELIANCE SPINAL SCREW SYSTEM

K123521 · Reliance Medical Systems, LLC · Orthopedic
Feb 2013
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K123521 is an FDA 510(k) clearance for the RELIANCE SPINAL SCREW SYSTEM, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Reliance Medical Systems, LLC (Bountiful, US). The FDA issued a Cleared decision on February 7, 2013, 84 days after receiving the submission on November 15, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K123521 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 2012
Decision Date February 07, 2013
Days to Decision 84 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MNI — Orthosis, Spinal Pedicle Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3070

Similar Devices — MNI Orthosis, Spinal Pedicle Fixation

All 302
Mikron Spinal Fixation System
K171497 · Mikron Makina Sanayi Ticaret Co. , Ltd. · Oct 2017
LumFix Spinal Fixation Sytem
K160731 · CG Bio Co., Ltd. · Oct 2016
Double Medical Universal Spine System
K151458 · Double Medical Technology, Inc. · Aug 2016
MySpine Pedicle Screw Placement Guides - LP
K153273 · Medacta International S.A. · Jun 2016
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System
K160124 · Spinevision S.A. · Apr 2016
Premier
K160320 · Shandong Weigao Orthopaedic Device Co., Ltd. · Apr 2016