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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 K193214
Device Name WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws
Applicant
Biomet, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact Janine Kem
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact Janine Kem
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received11/21/2019
Decision Date 11/10/2020
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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