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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 K190057
Device Name DJO Acetabular System
Applicant
Encore Medical, L.P.
9800 Metric Blvd.
Austin,  TX  78758
Applicant Contact Teffany Hutto
Correspondent
Encore Medical, L.P.
9800 Metric Blvd.
Austin,  TX  78758
Correspondent Contact Teffany Hutto
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
OQG  
Date Received01/11/2019
Decision Date 06/07/2019
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
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