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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K212996
Device Name Sterile PHALINX Hammertoe System
Applicant
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  37117
Applicant Contact Michael Mullins
Correspondent
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  37117
Correspondent Contact Michael Mullins
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTY  
Date Received09/20/2021
Decision Date 11/16/2021
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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