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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K223252
Device Name TRULIANT® E-PX Tibial Inserts; TRULIANT® E-PX Patellas
Applicant
Exactech, Inc
2320 NW 66th Ct
Gainesville,  FL  32653
Applicant Contact Elizabeth Howell
Correspondent
Exactech, Inc
2320 NW 66th Ct
Gainesville,  FL  32653
Correspondent Contact Elizabeth Howell
Regulation Number888.3560
Classification Product Code
JWH  
Subsequent Product Code
OIY  
Date Received10/21/2022
Decision Date 07/17/2023
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
Recalls CDRH Recalls
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