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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 K180024
Device Name SALVATION Midfoot Nail
Applicant
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  37117
Applicant Contact Alayne Melancon
Correspondent
Wrightmedicaltechnologyinc
1023 Cherry Rd.
Memphis,  TN  38117
Correspondent Contact Alayne Melancon
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/03/2018
Decision Date 07/11/2018
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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