VK100 Percutaneous Vertebral Augmentation System
K-Number: K192403 · 2019-11-08
ApplicantBonwrx, Ltd.
Decision Date2019-11-08
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
VK100 Percutaneous Vertebral Augmentation System is a medical device manufactured by Bonwrx, Ltd.. It received FDA 510(k) clearance on 2019-11-08 under approval number K192403. 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 VK100 Percutaneous Vertebral Augmentation System?
VK100 Percutaneous Vertebral Augmentation System is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by Bonwrx, Ltd.. The 510(k) number is K192403.
When was VK100 Percutaneous Vertebral Augmentation System approved by the FDA?
VK100 Percutaneous Vertebral Augmentation System received FDA 510(k) clearance on 2019-11-08, under approval number K192403.
What company makes VK100 Percutaneous Vertebral Augmentation System?
VK100 Percutaneous Vertebral Augmentation System is manufactured by Bonwrx, Ltd..
What is the FDA product code for VK100 Percutaneous Vertebral Augmentation System?
The FDA product code for VK100 Percutaneous Vertebral Augmentation System is NDN.
Related Clinical Trials
NCT05003843
BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
ACTIVE_NOT_RECRUITING
NCT07296744
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
RECRUITING
NCT07523620
Comprehensive LEFt Atrial Appendage Occlusion With Rhythm Restoration
RECRUITING
NCT06795763
Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures
ENROLLING_BY_INVITATION
NCT05505513
Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?
RECRUITING
NCT06315023
The Percutaneous Transmural Arterial Bypass -1 Study (Post Approval Registry)
ENROLLING_BY_INVITATION
Related PubMed Literature
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.