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— 510(k) K191212

Name: FDA 510(k) clearance K191212
Creator: U.S. Food and Drug Administration
Published: 2019-09-24

Substantially Equivalent

Medos International SARL

FDA 510(k) clearance K191212 for 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, Substantially Equivalent on 2019-09-24. Applicant: Medos International SARL. Device class: 2.

Clearance details

Applicant: Medos International SARL
Product code: Code PGM
Device class: Class 2
Regulation: 21 CFR 888.3070
Advisory panel: Orthopedic
Date received: 2019-05-06
Decision date: 2019-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lelocle, CH

Download summary PDF View on FDA.gov ↗

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