Cleared Traditional

CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System

K191212 · Medos International SARL · Orthopedic

Sep 2019

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K191212 is an FDA 510(k) clearance for the CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System, a Growing Rod System (Class II — Special Controls, product code PGM), submitted by Medos International SARL (Lelocle, CH). The FDA issued a Cleared decision on September 24, 2019, 141 days after receiving the submission on May 6, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K191212 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2019
Decision Date	September 24, 2019
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PGM — Growing Rod System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Stabilization Or Correction Of Spinal Deformities Without The Use Of Fusion.