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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, bone, vertebroplasty
510(k) Number K192403
Device Name VK100 Percutaneous Vertebral Augmentation System
Applicant
BONWRx Ltd
924 Terminal Road
Lansing,  MI  48906
Applicant Contact Ralph W. Carmichael
Correspondent
M Squared Associates, Inc
575 8th Avenue, Suite 1212
New York,  NY  10018
Correspondent Contact Connie Qiu
Regulation Number888.3027
Classification Product Code
NDN  
Date Received09/03/2019
Decision Date 11/08/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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