Cleared Traditional

VCFix Spinal System

K250637 · Amber Implants · Orthopedic

May 2025

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K250637 is an FDA 510(k) clearance for the VCFix Spinal System, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Amber Implants (The Hague, NL). The FDA issued a Cleared decision on May 30, 2025, 88 days after receiving the submission on March 3, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number	K250637 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2025
Decision Date	May 30, 2025
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF