Cleared Traditional

MySpine Pedicle Screw Placement Guides - LP

K153273 · Medacta International S.A. · Orthopedic
Jun 2016
Decision
230d
Days
Class 2
Risk

About This 510(k) Submission

K153273 is an FDA 510(k) clearance for the MySpine Pedicle Screw Placement Guides - LP, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Medacta International S.A. (Castel San Pietro, CH). The FDA issued a Cleared decision on June 29, 2016, 230 days after receiving the submission on November 12, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K153273 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2015
Decision Date June 29, 2016
Days to Decision 230 days
Submission Type Traditional
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
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
Sniper (R) Spine System
K160003 · Spine Wave, Inc. · Feb 2016