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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K250637
Device Name VCFix Spinal System
Applicant
Amber Implants
Prinses Beatrixlaan 546
The Hague,  NL 2595 BM
Applicant Contact Banafsheh Sajadi
Correspondent
Amber Implants
Prinses Beatrixlaan 546
The Hague,  NL 2595 BM
Correspondent Contact Banafsheh Sajadi
Regulation Number888.3027
Classification Product Code
NDN  
Date Received03/03/2025
Decision Date 05/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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