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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 K181794
Device Name Truliant Porous Femoral Components
Exactech, Inc.
2320 NW 66th CT
Gainesville,  FL  32653
Applicant Contact Patrick Hughes
Exactech, Inc.
2320 NW 66th CT
Gainesville,  FL  32653
Correspondent Contact Patrick Hughes
Regulation Number888.3565
Classification Product Code
Subsequent Product Code
Date Received07/05/2018
Decision Date 09/28/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No