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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, semi-constrained, metal/polymer, porous uncemented
510(k) Number K182502
Device Name Alteon Acetabular Cup System
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 Number888.3358
Classification Product Code
Subsequent Product Codes
Date Received09/12/2018
Decision Date 03/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls