FDA 510(k)

V-STRUT Vertebral Implant

K-Number: K191709 · 2020-03-05

Decision Date2020-03-05

Product CodeNDN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

V-STRUT Vertebral Implant is a medical device manufactured by Hyprevention Sas. It received FDA 510(k) clearance on 2020-03-05 under approval 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. It is manufactured by Hyprevention Sas. The 510(k) number is K191709.

When was V-STRUT Vertebral Implant approved by the FDA?

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

What company makes V-STRUT Vertebral Implant?

V-STRUT Vertebral Implant is manufactured by Hyprevention Sas.

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

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

Related Clinical Trials

NCT05337696 Circumferential Vertebral Reconstruction of Osteoporotic Compression Fractures Using a Novel Bipedicular Peek Implant TERMINATED NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

Related Devices (Code: NDN)

K16245313G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Mini-Flex)Pan Medical , Ltd. K160983Kyphon HV-R Bone CementMedtronic, Inc. K153296MEDINAUT Kyphoplasty SystemImedicom Co., Ltd. K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon CathetersG21, S.R.L. K172214Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L. K161114HIGH V+Teknimed Sas

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.