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FDA 510(k)

VCFix Spinal System

K-Number: K250637 · 2025-05-30

ApplicantAmber Implants
Decision Date2025-05-30
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VCFix Spinal System is a medical device manufactured by Amber Implants. It received FDA 510(k) clearance on 2025-05-30 under approval number K250637. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VCFix Spinal System?

VCFix Spinal System is a medical device that received FDA 510(k) clearance on 2025-05-30. It is manufactured by Amber Implants. The 510(k) number is K250637.

When was VCFix Spinal System approved by the FDA?

VCFix Spinal System received FDA 510(k) clearance on 2025-05-30, under approval number K250637.

What company makes VCFix Spinal System?

VCFix Spinal System is manufactured by Amber Implants.

What is the FDA product code for VCFix Spinal System?

The FDA product code for VCFix Spinal System is NDN.

Related Clinical Trials

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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