Adapting versatile
polymers to improve
surgical outcomes
and patient recovery

NEUROLAC®

Regulatory

Polyganics' quality system complies to ISO 13485, and dictates quality management standards and requirements for a comprehensive management system for design, manufacturing and distribution of medical devices. Polyganics also intends to comply with the USA FDA 21 CFR 820 corresponding subparts. The Polyganics' Quality Management System is ISO13485:2003 certified by Dekra Certification BV.

Classification details NEUROLAC®

European market Device class: Class III
EC Notified Body  Identification number: 0344
Notified body Dekra
   
US market

Device Class 2; FDA 510(k) number:

K032115 (1,5 - 3mm)
K050573 (4 - 10mm)
K112267 (TW)

 

Product Code JXI
Regulation number 21 CFR 882.5275
Medical Specialty Neurology
Owner/Operator Polyganics
Owner/Operator number 9057333
Establishment registration number 3004504732