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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 K141011
Device Name G-FORCE GEN 2 SUTURE ANCHOR SYSTEM
Applicant
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  38117
Applicant Contact DMITRI FALKNER
Correspondent
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  38117
Correspondent Contact DMITRI FALKNER
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received04/18/2014
Decision Date 07/30/2014
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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