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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 Rd.
Lansing,  MI  48906
Applicant Contact Ralph W. Carmichael
Correspondent
Msquared Associates, Inc.
575 8th Ave.
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
Predetermined Change
Control Plan Authorized		 No
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