FDA.report

510(k) K250637

Device
VCFix Spinal System
Applicant
Amber Implants
510(k) number
K250637
Product code
NDN
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-30
Date received
2025-03-03
Regulation
888.3027
Classification name
Cement, Bone, Vertebroplasty
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Banafsheh Sajadi
Address
Prinses Beatrixlaan 546 The Hague NL 2595 BM 2595 BM

FDA Registration Numbers

Source Documents

510(k) summary PDF

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