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510(k) K250637

VCFix Spinal System by Amber Implants — Product Code NDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2025
Date Received
March 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Bone, Vertebroplasty
Device Class
Class II
Regulation Number
888.3027
Review Panel
OR
Submission Type

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