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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K193108
Device Name Bonecam Suture Anchor
Applicant
Valeris Medical, Inc.
200 Cobb Pkwy. N.
Bldg. 200, Suite 210
Marietta,  GA  30062
Applicant Contact Brendan Thies
Correspondent
Valeris Medical, Inc.
200 Cobb Pkwy. N.
Bldg. 200, Suite 210
Marietta,  GA  30062
Correspondent Contact Brendan Thies
Regulation Number888.3040
Classification Product Code
MBI  
Date Received11/08/2019
Decision Date 03/26/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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