We make legally safe Orthopedic Implants in India for global requirement
 
 
Certifications
 
 
SHPOPL has following regulatory approvals from various authorities except for CE Certification which is under renewal with respect to new MDR guidelines.
 
 
 
 
 
 
U.S.FDA ISO 13485:2016 TUV ISO 13485:2016 LMS
     
     
     
ISO 17025   FDA 510(K)
Implant Testing Lab CDSCO Licence Rail & ALFA Fixator
     

     
     
FDA 510(K) FDA 510(K) FDA 510(K)
Plates & Screws Ring Fixator DEFTFIX
     
     
 
Gazette Notification Public notice by FDA Awareness campaign
 
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