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FDA 510(k)

V-STRUT Vertebral Implant

K-Number: K191709 · 2020-03-05

ApplicantHyprevention Sas
Decision Date2020-03-05
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 Sas. It received FDA 510(k) clearance on 2020-03-05 under 510(k) number K191709. 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 2020-03-05. The listed applicant is Hyprevention Sas. The 510(k) number is K191709.

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

V-STRUT Vertebral Implant received FDA 510(k) clearance on 2020-03-05, under 510(k) number K191709.

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

The FDA 510(k) record lists Hyprevention Sas 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 ImplantsK243537XeliteMed 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 ImplantHyprevention

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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