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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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(k) Number K240393
Device Name Exactech® TRULIANT® Knee System
Applicant
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Applicant Contact Liz Howell
Correspondent
Exactech, Inc.
2320 NW 66th Ct.
Gainesville,  FL  32653
Correspondent Contact Liz Howell
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received02/08/2024
Decision Date 10/03/2024
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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