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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 K182346
Device Name TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws
Applicant
Exactech, Inc.
2320 N.W. 66th Court
Gainesville,  FL  32653
Applicant Contact Meredith May
Correspondent
Empirical Consulting LLC
4628 Northpark Dr
Colorado Springs,  CO  80918
Correspondent Contact Meredith Lee May
Regulation Number888.3565
Classification Product Code
MBH  
Subsequent Product Code
JWH  
Date Received08/28/2018
Decision Date 11/26/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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