K191212

Substantially Equivalent

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

Applicant: Medos International SARL
Product code: PGM
Advisory panel: Orthopedic
Date received: 2019-05-06
Decision date: 2019-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lelocle, CH

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Data sourced from openFDA. This site is unofficial and independent of the FDA.