VK100 Percutaneous Vertebral Augmentation System

Cement, Bone, Vertebroplasty

BONWRx Ltd

The following data is part of a premarket notification filed by Bonwrx Ltd with the FDA for Vk100 Percutaneous Vertebral Augmentation System.

Pre-market Notification Details

Device IDK192403
501k NumberK192403
Device Name:VK100 Percutaneous Vertebral Augmentation System
ClassificationCement, Bone, Vertebroplasty
Applicant BONWRx Ltd 924 Terminal Road Lansing,  MI  48906
ContactRalph W Charmichael
CorrespondentConnie Qiu
M Squared Associates, Inc 575 8th Avenue, Suite 1212 Lansing,  NY  10018
Product CodeNDN  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-03
Decision Date2019-11-08

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