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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K222835
Device Name Prophecy Preoperative Navigation Alignment System
Applicant
Wrightmedicaltechnologyinc
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Applicant Contact Paxia Her
Correspondent
Wrightmedicaltechnologyinc
10801 Nesbitt Ave. S.
Bloomington,  MN  55437
Correspondent Contact Paxia Her
Regulation Number888.3110
Classification Product Code
HSN  
Subsequent Product Codes
OYK   PBF  
Date Received09/20/2022
Decision Date 01/27/2023
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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