FDA 510(k) Applications Submitted by Guilherme Pires

FDA 510(k) Number Submission Date Device Name Applicant
K240086 01/11/2024 Ion 3D SurGenTec, LLC
K240664 03/08/2024 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) SurGenTec, LLC
K240720 03/15/2024 TiLink-P SI Joint Fusion System SurGenTec, LLC
K243945 12/20/2024 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) SurGenTec LLC
K243949 12/23/2024 OsteoFlo HydroFiber SurGenTec, LLC


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact