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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 the device name listed in this FDA 510(k) record. The listed applicant is Amber Implants. It received FDA 510(k) clearance on 2025-05-30 under 510(k) 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. The listed applicant is Amber Implants. The 510(k) number is K250637.

When did VCFix Spinal System receive FDA 510(k) clearance?

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

Who is the listed applicant for VCFix Spinal System?

The FDA 510(k) record lists Amber Implants as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VCFix Spinal System?

The FDA product code for VCFix Spinal System is NDN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07259811Vertebral Augmentation Using VCFix Spinal System in Stand-alone ConfigurationACTIVE_NOT_RECRUITINGNCT07301749A Clinical Study Evaluating the Safety and Efficacy of the VCFix Spinal System for Treatment of Vertebral Compression FracturesRECRUITING

Related Devices (Code: NDN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251896XeliteMed SuperM-Fix Spinal Bone CementXelite Biomed , Ltd.K243537XeliteMed VertehighFix High Viscosity Spinal Bone Cement SystemXelite Biomed , Ltd.K241775XeliteMed VertehighFix High Viscosity Spinal Bone CementXelite Biomed , Ltd.K232842Balloon Inflation SystemNingbo Hicren Biotechnology Co., Ltd.K240084V-STRUT® Vertebral ImplantHypreventionK231340Renova Spine Balloon CatheterBiopsybell S.R.L.

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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