Cleared Special

MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM

K022190 · Depuyacromed · Orthopedic
Jul 2002
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K022190 is an FDA 510(k) clearance for the MODIFICATION TO SUMMIT OCCIPITO-CERVICO-THORACIC (OCT) SPINAL SYSTEM, a Orthosis, Spinal Pedicle Fixation (Class II — Special Controls, product code MNI), submitted by Depuyacromed (Raynham, US). The FDA issued a Cleared decision on July 24, 2002, 19 days after receiving the submission on July 5, 2002. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number K022190 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2002
Decision Date July 24, 2002
Days to Decision 19 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