FDA 510(k)

V-STRUT® Vertebral Implant

K-Number: K240084 · 2024-02-09

Decision Date2024-02-09

Product CodeNDN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

V-STRUT® Vertebral Implant is the device name listed in this FDA 510(k) record. The listed applicant is Hyprevention. It received FDA 510(k) clearance on 2024-02-09 under 510(k) number K240084. 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 V-STRUT® Vertebral Implant?

V-STRUT® Vertebral Implant is a medical device that received FDA 510(k) clearance on 2024-02-09. The listed applicant is Hyprevention. The 510(k) number is K240084.

When did V-STRUT® Vertebral Implant receive FDA 510(k) clearance?

V-STRUT® Vertebral Implant received FDA 510(k) clearance on 2024-02-09, under 510(k) number K240084.

Who is the listed applicant for V-STRUT® Vertebral Implant?

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

What is the FDA product code for V-STRUT® Vertebral Implant?

The FDA product code for V-STRUT® Vertebral Implant is NDN.

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.K250637VCFix Spinal SystemAmber Implants 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.K231340Renova 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.